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Legal Senior Regulatory Analyst (HS/IRB) (Part-Time) at Ripple Effect

Reviews human subjects research complaints and regulatory documentation to ensure compliance with federal research protection standards and supports institutional review board oversight.

Senior Remote Posted about 14 hours ago RemoteFirstJobs Product
What this role involves
  • Job Code: SHR-RA-04T
  • Location: Ripple Effect Headquarters – Rockville, MD
  • Employee Type: Exempt, Part-Time Regular
  • Telework: Full-time (this role is fully remote with a preference for local, or within local driving distance to HHS badging location)
  • Clearance: Public Trust
  • Salary Range: $49.23 - $56.62 per hour (how we pay and promote)

Are you passionate about bridging science and strategy to drive progress forward? Are you interested in helping ensure that human subjects research is conducted ethically and in compliance with federal regulations?

Ripple Effect is seeking a Senior Regulatory Analyst (HS/IRB) to support the Office for Human Research Protections (OHRP) within the U.S. Department of Health and Human Services (HHS). In this role, you will support OHRP’s compliance oversight mission by reviewing complaints, incident reports, and institutional submissions related to human subjects research. You will assist with the evaluation of compliance matters, conduct preliminary assessments, review regulatory documentation, and support case management activities involving Institutional Review Boards (IRBs), research institutions, and investigators. Additionally, you will apply your knowledge of the Common Rule (45 CFR 46), human research protections, and research compliance requirements to identify potential issues, support compliance reviews, and help develop recommendations for leadership consideration. Strong attention to detail, analytical thinking, and written communication skills are essential as you help maintain accurate records, prepare reports, and support the protection of research participants across a diverse research landscape.

If this position sounds of interest, there’s a place for you here at Ripple Effect! We offer a diverse and engaging work environment, meaningful opportunities to support an important public health mission, and flexible work options that support your lifestyle and professional growth.

Responsibilities

  • Technical Execution : Be the first point of contact for communications between internal and external parties. Receive and review complaints and incident report documents for completeness, accuracy, potential participant safety concerns, and regulatory significance

  • Communication and Documentation : Provide preliminary assessment for complaints and incident reports to agency leadership. Draft correspondence, information requests, case summaries, briefing materials, and status reports. Communicate professionally with research institutions, IRB personnel, investigators, complainants, and government officials. Request and collect additional information necessary to support compliance evaluations. Present analyses and recommendations to supervisors and compliance review teams. Participate in internal case review meetings and support leadership reporting activities, Develops a wide range of deliverables including reports, communication logs, trackers, briefing decks, and training materials, ensuring clarity and consistency.

  • Schedule and Timelines : Track case status, milestones, correspondence, and required follow-up activities. Ensure records management practices support transparency, quality assurance, and audit readiness.

  • Quality Management : Ensures deliverables meet quality standards and guidelines for format, content, and accessibility, and contributes to continuous improvement efforts.

  • Regulatory Compliance and Data Analysis : Applies working knowledge of regulatory and contractual requirements and contributes to content development and compliance procedures for the agency, Assist in monitoring and communicating institutional corrective actions and resolution of compliance matters, Analyze research documentation, IRB records, investigator information, institutional responses

  • Problem Solving & Continuous Improvement : Contributes to new processes and procedures to enhance team effectiveness and efficiency and proposes solutions to complex issues.

  • Supervision: Works under general direction, executes assignments independently, and keeps supervisor updated.

  • Performs other job-related duties as assigned.

Minimum Education and Experience

  • Master’s degree in public health, clinical research, health sciences, biomedical sciences, regulatory affairs, law, public administration, or a related field.

  • 8+ years relevant experience, additional education substitutes for experience.

Basic Requirements

  • Demonstrated experience related to human subjects research protections and regulatory compliance including-

    • Reviewing or supporting compliance activities related to human subjects research.
    • Working with Institutional Review Boards (IRBs), Human Research Protection Programs (HRPPs), research compliance offices, or regulatory oversight organizations.
    • Applying federal regulations governing human subjects research, including 45 CFR 46 (Common Rule).
    • Evaluating research protocols, incident reports, complaints, audit findings, or compliance documentation.
    • Preparing written analyses, regulatory summaries, reports, or compliance correspondence.
    • Managing sensitive information and maintaining detailed records with a high degree of accuracy.
  • Basic knowledge of project management software such as Microsoft Planner, Microsoft Project, Asana and Smartsheet.

  • Exceptional attention to detail, demonstrated ability to execute instructions, and commitment to quality and compliance.

  • Intermediate experience with Microsoft Office productivity software and collaboration tools such as Microsoft Teams and SharePoint.

Skills that Set You Apart

  • Advanced degree Preferred.
  • Certificates in project management, CIP (Certified IRB Professional), CCRP, CHRC, or related research compliance credential recommended
  • Foundational knowledge of technical writing in areas including process documentation, briefing decks, status reports, memos and other business writing.
  • Basic knowledge of AI tools, including their limitations and risks, and how they can be applied to support project management tasks.
  • Experience in academic medical centers, research institutions, federal agencies, or compliance oversight organizations.
  • Familiarity with electronic compliance or case management systems and document management tools.

About Ripple Effect

Ripple Effect is a woman-owned, 200-person company of communicators, scientists, researchers, and analysts. Established in 2003, and named as one of the “Best and Brightest Companies to Work For” in 2024 and 2025 by the NABR, Ripple Effect has earned acclaim for delivering unparalleled consulting services and top-tier talent across federal, private, and non-profit sectors.

At Ripple Effect, we reward our employees for their contributions to our mission. Our comprehensive total rewards package includes competitive pay, exceptional benefits, and a range of programs that support your work/life balance and personalized preferences.

Learn more about our benefits and culture here.

Read the full description
Legal Senior Regulatory Analyst (HS/IRB) (Part-Time) at Ripple Effect

Reviews human subjects research compliance matters, incident reports, and regulatory documentation to support federal oversight and protect research participants.

Senior Remote Posted about 14 hours ago RemoteFirstJobs Product
What this role involves
  • Job Code: SHR-RA-04T
  • Location: Ripple Effect Headquarters – Rockville, MD
  • Employee Type: Exempt, Part-Time Regular
  • Telework: Full-time (this role is fully remote with a preference for local, or within local driving distance to HHS badging location)
  • Clearance: Public Trust
  • Salary Range: $49.23 - $56.62 per hour (how we pay and promote)

Are you passionate about bridging science and strategy to drive progress forward? Are you interested in helping ensure that human subjects research is conducted ethically and in compliance with federal regulations?

Ripple Effect is seeking a Senior Regulatory Analyst (HS/IRB) to support the Office for Human Research Protections (OHRP) within the U.S. Department of Health and Human Services (HHS). In this role, you will support OHRP’s compliance oversight mission by reviewing complaints, incident reports, and institutional submissions related to human subjects research. You will assist with the evaluation of compliance matters, conduct preliminary assessments, review regulatory documentation, and support case management activities involving Institutional Review Boards (IRBs), research institutions, and investigators. Additionally, you will apply your knowledge of the Common Rule (45 CFR 46), human research protections, and research compliance requirements to identify potential issues, support compliance reviews, and help develop recommendations for leadership consideration. Strong attention to detail, analytical thinking, and written communication skills are essential as you help maintain accurate records, prepare reports, and support the protection of research participants across a diverse research landscape.

If this position sounds of interest, there’s a place for you here at Ripple Effect! We offer a diverse and engaging work environment, meaningful opportunities to support an important public health mission, and flexible work options that support your lifestyle and professional growth.

Responsibilities

  • Technical Execution : Be the first point of contact for communications between internal and external parties. Receive and review complaints and incident report documents for completeness, accuracy, potential participant safety concerns, and regulatory significance

  • Communication and Documentation : Provide preliminary assessment for complaints and incident reports to agency leadership. Draft correspondence, information requests, case summaries, briefing materials, and status reports. Communicate professionally with research institutions, IRB personnel, investigators, complainants, and government officials. Request and collect additional information necessary to support compliance evaluations. Present analyses and recommendations to supervisors and compliance review teams. Participate in internal case review meetings and support leadership reporting activities, Develops a wide range of deliverables including reports, communication logs, trackers, briefing decks, and training materials, ensuring clarity and consistency.

  • Schedule and Timelines : Track case status, milestones, correspondence, and required follow-up activities. Ensure records management practices support transparency, quality assurance, and audit readiness.

  • Quality Management : Ensures deliverables meet quality standards and guidelines for format, content, and accessibility, and contributes to continuous improvement efforts.

  • Regulatory Compliance and Data Analysis : Applies working knowledge of regulatory and contractual requirements and contributes to content development and compliance procedures for the agency, Assist in monitoring and communicating institutional corrective actions and resolution of compliance matters, Analyze research documentation, IRB records, investigator information, institutional responses

  • Problem Solving & Continuous Improvement : Contributes to new processes and procedures to enhance team effectiveness and efficiency and proposes solutions to complex issues.

  • Supervision: Works under general direction, executes assignments independently, and keeps supervisor updated.

  • Performs other job-related duties as assigned.

Minimum Education and Experience

  • Master’s degree in public health, clinical research, health sciences, biomedical sciences, regulatory affairs, law, public administration, or a related field.

  • 8+ years relevant experience, additional education substitutes for experience.

Basic Requirements

  • Demonstrated experience related to human subjects research protections and regulatory compliance including-

    • Reviewing or supporting compliance activities related to human subjects research.
    • Working with Institutional Review Boards (IRBs), Human Research Protection Programs (HRPPs), research compliance offices, or regulatory oversight organizations.
    • Applying federal regulations governing human subjects research, including 45 CFR 46 (Common Rule).
    • Evaluating research protocols, incident reports, complaints, audit findings, or compliance documentation.
    • Preparing written analyses, regulatory summaries, reports, or compliance correspondence.
    • Managing sensitive information and maintaining detailed records with a high degree of accuracy.
  • Basic knowledge of project management software such as Microsoft Planner, Microsoft Project, Asana and Smartsheet.

  • Exceptional attention to detail, demonstrated ability to execute instructions, and commitment to quality and compliance.

  • Intermediate experience with Microsoft Office productivity software and collaboration tools such as Microsoft Teams and SharePoint.

Skills that Set You Apart

  • Advanced degree Preferred.
  • Certificates in project management, CIP (Certified IRB Professional), CCRP, CHRC, or related research compliance credential recommended
  • Foundational knowledge of technical writing in areas including process documentation, briefing decks, status reports, memos and other business writing.
  • Basic knowledge of AI tools, including their limitations and risks, and how they can be applied to support project management tasks.
  • Experience in academic medical centers, research institutions, federal agencies, or compliance oversight organizations.
  • Familiarity with electronic compliance or case management systems and document management tools.

About Ripple Effect

Ripple Effect is a woman-owned, 200-person company of communicators, scientists, researchers, and analysts. Established in 2003, and named as one of the “Best and Brightest Companies to Work For” in 2024 and 2025 by the NABR, Ripple Effect has earned acclaim for delivering unparalleled consulting services and top-tier talent across federal, private, and non-profit sectors.

At Ripple Effect, we reward our employees for their contributions to our mission. Our comprehensive total rewards package includes competitive pay, exceptional benefits, and a range of programs that support your work/life balance and personalized preferences.

Learn more about our benefits and culture here.

Read the full description
Legal Senior Regulatory Analyst (HS/IRB) (Part-Time) at Ripple Effect

Reviews human subjects research complaints and regulatory submissions for compliance with federal regulations, supports IRB oversight, and prepares documentation for HHS leadership.

Senior Remote Posted about 14 hours ago RemoteFirstJobs Product
What this role involves
  • Job Code: SHR-RA-04T
  • Location: Ripple Effect Headquarters – Rockville, MD
  • Employee Type: Exempt, Part-Time Regular
  • Telework: Full-time (this role is fully remote with a preference for local, or within local driving distance to HHS badging location)
  • Clearance: Public Trust
  • Salary Range: $49.23 - $56.62 per hour (how we pay and promote)

Are you passionate about bridging science and strategy to drive progress forward? Are you interested in helping ensure that human subjects research is conducted ethically and in compliance with federal regulations?

Ripple Effect is seeking a Senior Regulatory Analyst (HS/IRB) to support the Office for Human Research Protections (OHRP) within the U.S. Department of Health and Human Services (HHS). In this role, you will support OHRP’s compliance oversight mission by reviewing complaints, incident reports, and institutional submissions related to human subjects research. You will assist with the evaluation of compliance matters, conduct preliminary assessments, review regulatory documentation, and support case management activities involving Institutional Review Boards (IRBs), research institutions, and investigators. Additionally, you will apply your knowledge of the Common Rule (45 CFR 46), human research protections, and research compliance requirements to identify potential issues, support compliance reviews, and help develop recommendations for leadership consideration. Strong attention to detail, analytical thinking, and written communication skills are essential as you help maintain accurate records, prepare reports, and support the protection of research participants across a diverse research landscape.

If this position sounds of interest, there’s a place for you here at Ripple Effect! We offer a diverse and engaging work environment, meaningful opportunities to support an important public health mission, and flexible work options that support your lifestyle and professional growth.

Responsibilities

  • Technical Execution : Be the first point of contact for communications between internal and external parties. Receive and review complaints and incident report documents for completeness, accuracy, potential participant safety concerns, and regulatory significance

  • Communication and Documentation : Provide preliminary assessment for complaints and incident reports to agency leadership. Draft correspondence, information requests, case summaries, briefing materials, and status reports. Communicate professionally with research institutions, IRB personnel, investigators, complainants, and government officials. Request and collect additional information necessary to support compliance evaluations. Present analyses and recommendations to supervisors and compliance review teams. Participate in internal case review meetings and support leadership reporting activities, Develops a wide range of deliverables including reports, communication logs, trackers, briefing decks, and training materials, ensuring clarity and consistency.

  • Schedule and Timelines : Track case status, milestones, correspondence, and required follow-up activities. Ensure records management practices support transparency, quality assurance, and audit readiness.

  • Quality Management : Ensures deliverables meet quality standards and guidelines for format, content, and accessibility, and contributes to continuous improvement efforts.

  • Regulatory Compliance and Data Analysis : Applies working knowledge of regulatory and contractual requirements and contributes to content development and compliance procedures for the agency, Assist in monitoring and communicating institutional corrective actions and resolution of compliance matters, Analyze research documentation, IRB records, investigator information, institutional responses

  • Problem Solving & Continuous Improvement : Contributes to new processes and procedures to enhance team effectiveness and efficiency and proposes solutions to complex issues.

  • Supervision: Works under general direction, executes assignments independently, and keeps supervisor updated.

  • Performs other job-related duties as assigned.

Minimum Education and Experience

  • Master’s degree in public health, clinical research, health sciences, biomedical sciences, regulatory affairs, law, public administration, or a related field.

  • 8+ years relevant experience, additional education substitutes for experience.

Basic Requirements

  • Demonstrated experience related to human subjects research protections and regulatory compliance including-

    • Reviewing or supporting compliance activities related to human subjects research.
    • Working with Institutional Review Boards (IRBs), Human Research Protection Programs (HRPPs), research compliance offices, or regulatory oversight organizations.
    • Applying federal regulations governing human subjects research, including 45 CFR 46 (Common Rule).
    • Evaluating research protocols, incident reports, complaints, audit findings, or compliance documentation.
    • Preparing written analyses, regulatory summaries, reports, or compliance correspondence.
    • Managing sensitive information and maintaining detailed records with a high degree of accuracy.
  • Basic knowledge of project management software such as Microsoft Planner, Microsoft Project, Asana and Smartsheet.

  • Exceptional attention to detail, demonstrated ability to execute instructions, and commitment to quality and compliance.

  • Intermediate experience with Microsoft Office productivity software and collaboration tools such as Microsoft Teams and SharePoint.

Skills that Set You Apart

  • Advanced degree Preferred.
  • Certificates in project management, CIP (Certified IRB Professional), CCRP, CHRC, or related research compliance credential recommended
  • Foundational knowledge of technical writing in areas including process documentation, briefing decks, status reports, memos and other business writing.
  • Basic knowledge of AI tools, including their limitations and risks, and how they can be applied to support project management tasks.
  • Experience in academic medical centers, research institutions, federal agencies, or compliance oversight organizations.
  • Familiarity with electronic compliance or case management systems and document management tools.

About Ripple Effect

Ripple Effect is a woman-owned, 200-person company of communicators, scientists, researchers, and analysts. Established in 2003, and named as one of the “Best and Brightest Companies to Work For” in 2024 and 2025 by the NABR, Ripple Effect has earned acclaim for delivering unparalleled consulting services and top-tier talent across federal, private, and non-profit sectors.

At Ripple Effect, we reward our employees for their contributions to our mission. Our comprehensive total rewards package includes competitive pay, exceptional benefits, and a range of programs that support your work/life balance and personalized preferences.

Learn more about our benefits and culture here.

Read the full description
Legal Senior Counsel at GoodLeap

Senior Counsel provides legal guidance on mortgage/HELOC products, manages regulatory compliance, and advises on consumer credit and lending issues.

Senior Posted 1 day ago RemoteFirstJobs Product
What this role involves

About GoodLeap:

GoodLeap is a technology company delivering best-in-class financing and software products for sustainable solutions, from solar panels and batteries to energy-efficient HVAC, heat pumps, roofing, windows, and more. Over 1 million homeowners have benefited from our simple, fast, and frictionless technology that makes the adoption of these products more affordable, accessible, and easier to understand. Thousands of professionals deploying home efficiency and solar solutions rely on GoodLeap’s proprietary, AI-powered applications and developer tools to drive more transparent customer communication, deeper business intelligence, and streamlined payment and operations. Our platform has led to more than $27 billion in financing for sustainable solutions since 2018.

GoodLeap is also proud to support our award-winning nonprofit, GivePower, which is building and deploying life-saving water and clean electricity systems, changing the lives of more than 1.6 million people across Africa, Asia, and South America.

Responsible for providing direct legal support to mortgage/HELOC products and business units as Senior Counsel member of Legal Compliance team. Works with outside Counsel and in-house legal and paralegal team members. Provides advice on legal issues and supports all sectors of the business with regards to mortgage, consumer credit and related products and services.

Essential Job Duties and Responsibilities:

  • Manage and work on legal, regulatory, and product issues related to mortgage/HELOC financial products and business units, including managing and working with outside counsel and other business units.
  • Provide advice and support legal, regulatory, and product issues related to debt collection, privacy, consumer credit compliance, lending and solar financing. Ensures compliance with all applicable laws, regulations and Company policies and procedures.
  • Perform other tasks as assigned from time to time by the company.

Required Skills, Knowledge and Abilities:

  • Competence as a lawyer; ability to manage heavy workload in a high-pressure environment.
  • Good communication (oral and written) and interpersonal skills within and across departments and externally; must be proactive in providing counsel to clients.
  • Sound judgment: ability to clearly make reasoned recommendations; ability to cross think and determine who should be kept informed.
  • Self-starter with good business sense and a sense of urgency, honesty, and fairness.
  • Good team player, calm under pressure.
  • Self-confident and inspires confidence from clients.
  • Must have a JD degree from an accredited law school.
  • Candidate must have experience advising mortgage lenders, financial institutions or fintechs on legal and regulatory consumer credit lending issues.
  • Prefer candidate with experience handling mortgage/HELOC products, legal issues, litigation and consumer complaints, and examinations.
  • Committed to being a legal business partner to internal clients.

Compensation: $150,000 - $200,000 per year

Additional Information Regarding Job Duties and Job Descriptions:

Job duties include additional responsibilities as assigned by one’s supervisor or other managers related to the position/department. This job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and other skills required for the position. The Company reserves the right at any time with or without notice to alter or change job responsibilities, reassign or transfer job position or assign additional job responsibilities, subject to applicable law. The Company shall provide reasonable accommodations of known disabilities to enable a qualified applicant or employee to apply for employment, perform the essential functions of the job, or enjoy the benefits and privileges of employment as required by the law.

If you are an extraordinary professional who thrives in a collaborative work culture and values a rewarding career, then we want to work with you!  Apply today!

We are committed to protecting your privacy. To learn more about how we collect, use, and safeguard your personal information during the application process, please review out Employment Privacy Policy and Recruiting Policy on AI.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Read the full description
Legal Senior Counsel at GoodLeap

Provides legal counsel on mortgage/HELOC products, manages regulatory compliance, and advises on consumer credit and lending issues across business units.

Senior Posted 1 day ago RemoteFirstJobs Product
What this role involves

About GoodLeap:

GoodLeap is a technology company delivering best-in-class financing and software products for sustainable solutions, from solar panels and batteries to energy-efficient HVAC, heat pumps, roofing, windows, and more. Over 1 million homeowners have benefited from our simple, fast, and frictionless technology that makes the adoption of these products more affordable, accessible, and easier to understand. Thousands of professionals deploying home efficiency and solar solutions rely on GoodLeap’s proprietary, AI-powered applications and developer tools to drive more transparent customer communication, deeper business intelligence, and streamlined payment and operations. Our platform has led to more than $27 billion in financing for sustainable solutions since 2018.

GoodLeap is also proud to support our award-winning nonprofit, GivePower, which is building and deploying life-saving water and clean electricity systems, changing the lives of more than 1.6 million people across Africa, Asia, and South America.

Responsible for providing direct legal support to mortgage/HELOC products and business units as Senior Counsel member of Legal Compliance team. Works with outside Counsel and in-house legal and paralegal team members. Provides advice on legal issues and supports all sectors of the business with regards to mortgage, consumer credit and related products and services.

Essential Job Duties and Responsibilities:

  • Manage and work on legal, regulatory, and product issues related to mortgage/HELOC financial products and business units, including managing and working with outside counsel and other business units.
  • Provide advice and support legal, regulatory, and product issues related to debt collection, privacy, consumer credit compliance, lending and solar financing. Ensures compliance with all applicable laws, regulations and Company policies and procedures.
  • Perform other tasks as assigned from time to time by the company.

Required Skills, Knowledge and Abilities:

  • Competence as a lawyer; ability to manage heavy workload in a high-pressure environment.
  • Good communication (oral and written) and interpersonal skills within and across departments and externally; must be proactive in providing counsel to clients.
  • Sound judgment: ability to clearly make reasoned recommendations; ability to cross think and determine who should be kept informed.
  • Self-starter with good business sense and a sense of urgency, honesty, and fairness.
  • Good team player, calm under pressure.
  • Self-confident and inspires confidence from clients.
  • Must have a JD degree from an accredited law school.
  • Candidate must have experience advising mortgage lenders, financial institutions or fintechs on legal and regulatory consumer credit lending issues.
  • Prefer candidate with experience handling mortgage/HELOC products, legal issues, litigation and consumer complaints, and examinations.
  • Committed to being a legal business partner to internal clients.

Compensation: $150,000 - $200,000 per year

Additional Information Regarding Job Duties and Job Descriptions:

Job duties include additional responsibilities as assigned by one’s supervisor or other managers related to the position/department. This job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and other skills required for the position. The Company reserves the right at any time with or without notice to alter or change job responsibilities, reassign or transfer job position or assign additional job responsibilities, subject to applicable law. The Company shall provide reasonable accommodations of known disabilities to enable a qualified applicant or employee to apply for employment, perform the essential functions of the job, or enjoy the benefits and privileges of employment as required by the law.

If you are an extraordinary professional who thrives in a collaborative work culture and values a rewarding career, then we want to work with you!  Apply today!

We are committed to protecting your privacy. To learn more about how we collect, use, and safeguard your personal information during the application process, please review out Employment Privacy Policy and Recruiting Policy on AI.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Read the full description
Legal Senior Manager RA US Advertising and Promotion - Hybrid at AbbVie

Manages regulatory affairs for pharmaceutical advertising and promotion, ensuring compliance with FDA regulations while overseeing team development and policy analysis.

Senior Hybrid Posted 11 days ago RemoteFirstJobs Product
What this role involves

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Manager Regulatory Affairs US Advertising and Promotion-Immunology combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual share knowledge and expertise with others in support of team activities and analyzes broad scope implications of changing regulations and policies.

Responsibilities:

  • Proactively captures and disseminates activities of government, industry, and trade associations that impact pharmaceutical regulatory policies relative to AbbVie’s interests. Maintains awareness of pending changes to communicate impact and relevance within Regulatory Operations. Drafts and finalizes comments in a timely manner, to regulators and trade associations. Distributes proposed policies to SMEs. Highlights key points in a clear and concise manner.
  • Represents department and participates in trade associations as needed. Develops good working relationships with trade association managers.
  • Summarizes findings, under supervision, in concise reports for distribution within AbbVie
  • Oversee the operations productivity and development of assigned regulatory staff that are responsible for ensuring that advertising and promotion materials are accurate, competitive and compliant with internal policies. Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the FDA and cosmetic Act.
  • Development and guides implementation strategies for promotional activities
  • Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
  • Ensure departmental training and compliance with established regulations, guidance, promotional guidelines and SOPs related to advertising and promotion regulations for self and direct reports. Manages direct reports and assists in the development, training and mentoring of staff members
  • Effectively presents pertinent information to appropriate cross-functional groups.
  • Effectively delivers difficult messages to commercial organizations without damage to relationships
  • Establishes solid relationships with management and key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.) fostering mutually beneficial interactions and exchange.
  • This role will work a hybrid work schedule (3 days in office & 2 days remotely) from one of the following AbbVie headquarters; Lake County, IL; Florham Park, NJ; Irvine, CA
  • Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

  • Minimum: Bachelor’s degree in science (biology, chemistry, microbiology immunology, medical technology, pharmacy, pharmacology, nursing, pharmacy) plus 7 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
  • Preferred PharmD degree plus 5 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
  • Experience working in a complex and matrix environment and exhibits strong negotiation skills
  • Strong communication skills, both oral and written
  • Experience in management capacity preferred
  • Experience in US Regulatory Affairs Advertising and Promotion

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​

  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

  • This job is eligible to participate in our long-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Read the full description
Legal Senior Associate Regulatory Affairs Submission Management - Hybrid at AbbVie

Manages regulatory submission projects and timelines for pharmaceutical dossiers, coordinating cross-functional teams and vendor publishing to meet regulatory authority requirements.

Senior Hybrid Posted 11 days ago RemoteFirstJobs Product
What this role involves

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Associate, Regulatory Affairs Submission Management, manages medium to high impact, moderately complex submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams, this individual establishes and maintains submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, and fulfills Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications. This individual is recognized as very knowledgeable in their discipline expert and in regulatory affairs submission management.

Responsibilities:

  • Manages medium to high impact (with respect to internal visibility, risk, complexity and criticality) submission projects to ensure the timely delivery of high-quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency.
  • Acts as RA Submissions interface with project teams providing guidance and communication of established submission processes and standards. Provides input to project scope, especially as it impacts publishing timelines and deliverables.
  • Plans and conducts submission team meetings. Expedites, manages, and coordinates multiple concurrent interrelated activities for submission projects and/or for multiple products in the delivery of moderately complex published submissions within the required timelines. Anticipates obstacles and develop solutions within the team.
  • Coordinates submission publishing with offsite publishers/provides notification to ensure all required resources are available to meet submission timelines. Prepares content planner for publishing and works with vendor to resolve publishing issues. May perform in-house publishing tasks
  • May be a technical Subject Matter Expert troubleshooting issues and providing technical systems support.
  • Facilitates the creation or procurement of submission content deliverables such as cover letters and forms.
  • Performs detailed quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidances including verification of content, bookmarks, hypertext links and tables of content in moderately complex submissions. Facilitates team reviews.
  • Suggests and contributes to process improvements, including changes to software and business processes. May participate on internal project teams to update business software.
  • Demonstrates team leadership skills and ability to influence without direct authority. Builds and maintains positive relationships internally and externally.
  • Contributes to the development of optimal business processes and standards within the department to ensure high levels of customer support and to achieve high quality submissions.
  • Contributes to the creation, and implementation of internal process and standards documents relating to publishing and publishing deliverables.
  • Position accountability/scope:
    • Some supervision required
    • Receives project assignments from manager but has responsibility for managing own projects with some oversight
    • Reviews project progress with manager on a regular basis with direction provided by manager
    • Trains, and mentors less experienced staff.
  • This position will work a hybrid work schedule, 3 days in office & 2 days remote, from our AbbVie North Chicago, IL headquarters.

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

  • Required Education: Bachelor’s degree.
    • Note: Years of experience may also compensate for lower education.
    • Preferred Education: PMP and RAC certificates a plus
  • Required Experience: Four years’ pharmaceutical or industry related experience with publishing related software tools e.g. Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight platform, Adobe Acrobat.
  • Preferred Experience:
    • Experience in Regulatory Affairs preferred but may consider QA, R&D/support, Scientific affairs, operations or related area
    • Experience in Regulatory Operations, including regulatory submission project management and/or submission publishing is preferred.
    • Proven leadership skills and presence
    • NOTE: Higher education may compensate for years of experience.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at  the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors  including  geographic location, and we may ultimately  pay more or less than the posted range. This range may be  modified in the future. ​

  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

  • This job is eligible to  participate in our short-term incentive programs.  ​

Note: No amount of pay is  considered to be wages or compensation until such amount is earned,  vested,  and determinable. The amount and availability of  any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a   particular employee  remains in the Company’s sole and absolute discretion unless and until paid and may be  modified at the Company’s sole and absolute discretion,  consistent with applicable law. ​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Read the full description
Legal Senior Manager RA US Advertising and Promotion - Hybrid at AbbVie

Senior regulatory affairs manager ensures pharmaceutical advertising and promotion materials comply with FDA regulations, manages regulatory staff, and monitors policy changes affecting the company.

Senior Hybrid Posted 11 days ago RemoteFirstJobs Product
What this role involves

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Manager Regulatory Affairs US Advertising and Promotion-Immunology combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual share knowledge and expertise with others in support of team activities and analyzes broad scope implications of changing regulations and policies.

Responsibilities:

  • Proactively captures and disseminates activities of government, industry, and trade associations that impact pharmaceutical regulatory policies relative to AbbVie’s interests. Maintains awareness of pending changes to communicate impact and relevance within Regulatory Operations. Drafts and finalizes comments in a timely manner, to regulators and trade associations. Distributes proposed policies to SMEs. Highlights key points in a clear and concise manner.
  • Represents department and participates in trade associations as needed. Develops good working relationships with trade association managers.
  • Summarizes findings, under supervision, in concise reports for distribution within AbbVie
  • Oversee the operations productivity and development of assigned regulatory staff that are responsible for ensuring that advertising and promotion materials are accurate, competitive and compliant with internal policies. Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the FDA and cosmetic Act.
  • Development and guides implementation strategies for promotional activities
  • Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
  • Ensure departmental training and compliance with established regulations, guidance, promotional guidelines and SOPs related to advertising and promotion regulations for self and direct reports. Manages direct reports and assists in the development, training and mentoring of staff members
  • Effectively presents pertinent information to appropriate cross-functional groups.
  • Effectively delivers difficult messages to commercial organizations without damage to relationships
  • Establishes solid relationships with management and key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.) fostering mutually beneficial interactions and exchange.
  • This role will work a hybrid work schedule (3 days in office & 2 days remotely) from one of the following AbbVie headquarters; Lake County, IL; Florham Park, NJ; Irvine, CA
  • Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

  • Minimum: Bachelor’s degree in science (biology, chemistry, microbiology immunology, medical technology, pharmacy, pharmacology, nursing, pharmacy) plus 7 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
  • Preferred PharmD degree plus 5 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
  • Experience working in a complex and matrix environment and exhibits strong negotiation skills
  • Strong communication skills, both oral and written
  • Experience in management capacity preferred
  • Experience in US Regulatory Affairs Advertising and Promotion

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​

  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

  • This job is eligible to participate in our long-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Read the full description
Legal Senior Contracts and Budget Associate

Reviews, drafts, and negotiates legal agreements including CDAs, clinical trial agreements, and amendments while managing associated budgets and documentation.

Senior Posted 12 days ago Himalayas
What this role involves
Position Summary:Review, draft, negotiate and track a variety of legal agreements including confidentiality disclosure agreements (CDA), initial clinical trial agreements (CTA), amendments to the clinical trial agreements (CTA-A), site budgets and other various types of documents.
Read the full description
Legal Senior Regulatory Affairs Associate

Manages regulatory compliance, documentation, and submissions to ensure products meet legal and regulatory requirements.

Senior Posted 13 days ago Himalayas
What this role involves
When our values align, there's no limit to what we can achieve.
Read the full description
Legal Managing Counsel, Commercial (EMEA) at Remote

Senior commercial lawyer handles SaaS contract negotiations, enterprise deals, and partnership agreements while supporting the EMEA sales team.

Senior Remote Posted 14 days ago RemoteFirstJobs Product
What this role involves

About Remote

Remote is solving modern organizations’ biggest challenge – navigating global employment compliantly with ease. We make it possible for businesses of all sizes to recruit, pay, and manage international teams. With our core values at heart and future focused work culture, our team works tirelessly on ambitious problems, asynchronously, around the world. You can find Remoters working from 6 different continents (Antarctica left to go!) and all of our positions are fully remote.

With Innovation as one of the core values, we have built Automation and AI capabilities into the requirements for every role.

We encourage every member of the Remote team to bring their talents, experiences and culture to the table to help us build the best-in-class HR platform.

If you are energetic, curious, motivated and ambitious, be part of our world. Apply now and define the future of work!

What this job can offer you

This is an exciting time to join Remote and make a personal difference in the global HR-tech space as Managing Counsel - Commercial. We are looking for a seasoned and business-oriented commercial lawyer who is interested in helping with our team’s mission, namely: to deliver pragmatic and innovative legal solutions for Remote’s products and stakeholders while protecting Remote from unacceptable risk. This role is a senior individual contributor role with no managerial responsibilities. It will be part of the Employment, Product and Commercial Legal sub-team.

As an independent senior lawyer, you will primarily support our global commercial deals, as well as supporting embedded partnerships, resell, and other channel arrangements. You will provide critical support for the EMEA sales team, tag-teaming with the existing EMEA sales and DP counsel to ensure seamless regional coverage.

Remote’s well established Legal team is a bunch of friendly, talented and highly motivated lawyers from a whole host of different countries with some awesome experiences, and we are looking for a great match for them.

What you bring

  • Proven expertise in supporting commercial transactions, particularly enterprise-level SaaS agreements, Terms of Service negotiations, and sales contract reviews. Experience supporting sales teams in EMEA is highly valued.
  • Partnership and channel/reseller agreement experience is a strong plus, as we anticipate needs in structuring and negotiating strategic partnerships.
  • Prior HR Tech industry experience or familiarity with bespoke HR services agreements is beneficial, though not required.
  • Solid commercial drafting skills are critical for this role, with the ability to craft clear, precise, and enforceable agreements that protect Remote’s interests while facilitating business objectives.
  • Strong negotiation skills with the ability to develop creative, practical solutions for complex commercial and business challenges.
  • Sharp commercial instincts and strategic thinking, with a focus on driving business success while effectively navigating legal complexities. You are commercially minded and comfortable letting go of immaterial points in contract negotiations to keep deals moving forward efficiently.
  • Strong working knowledge of data protection laws, especially GDPR, is essential for managing data flows. Prior background in U.S. data protection laws is also a plus.
  • Proven ability to excel in a fast-paced environment, maintaining responsiveness and adaptability under pressure (you can take the heat and keep moving forward).
  • Strong capacity to work independently while collaborating effectively with Sales, Finance, Product and other functional teams—you’re confident in your expertise but always open to learning, and you prioritize team success over personal ego.
  • Outstanding ability to build trusted relationships with GTM stakeholders while maintaining independent legal judgment.
  • You know when to be flexible and when to push back firmly on unreasonable requests, always acting as a strategic business partner rather than a bottleneck.
  • A healthy dose of humor and humility that makes you a joy to work with.
  • Demonstrates strong automation and AI capabilities and AI fluency.

Key Responsibilities

  • Act as the primary legal advisor to our EMEA sales teams, providing timely and practical legal support on Terms of Service negotiation, contract redlining, and commercial agreement reviews—always prioritizing responsiveness, brevity and clarity.
  • Provide additional legal support to AMER sales teams as needed, ensuring consistent and high-quality legal guidance across regions.
  • Strategize, draft and negotiate partnership agreements and channel/reseller agreements as opportunities arise, supporting our growing partnership initiatives.
  • Partner closely with Sales, Finance and other cross-functional teams to structure and review commercial agreements that align with business objectives while mitigating legal and operational risks.
  • Develop and improve templates, playbooks, processes and other knowledge resources around commercial transactions and sales support.
  • Provide legal training and guidance to internal stakeholders, particularly sales teams, to empower them with the tools and knowledge necessary to navigate complex commercial issues effectively.
  • Bring a solutions-focused mindset to every negotiation, minimizing roadblocks and resolving issues without unnecessary escalation.

Practicals

  • You’ll report to: Director, Legal - Commercial
  • Team: Legal - Commercial (Direct Sales & Partnerships)
  • Location: For this position we welcome everyone to apply, but we will prioritize applications from EMEA time zones, with AMER East Coast time zone as secondary preference
  • Start date: As soon as possible

Application process

  1. Interview with recruiter
  2. Interview with hiring manager
  3. Written exercise
  4. Interview with legal team and stakeholders
  5. Bar Raiser Interview
  6. Reference check
  7. Prior employment verification check

Remote’s Total Rewards philosophy is to ensure fair, unbiased compensation and fair equity pay along with competitive benefits in all locations in which we operate. We do not agree to or encourage cheap-labor practices and therefore we ensure to pay above in-location rates. We hope to inspire other companies to support global talent-hiring and bring local wealth to developing countries.

At first glance our salary bands seem quite wide - here is some context. At Remote we have international operations and a globally distributed workforce.  We use geo ranges to consider geographic pay differentials as part of our global compensation strategy to remain competitive in various markets while we hiring globally.

Our salary ranges are determined by role, level and location, and our job titles may span more than one career level. The actual base pay for the successful candidate in this role is dependent upon many factors such as location, transferable or job-related skills, work experience, relevant training, business needs, and market demands. The base salary range may be subject to change.

At Remote, we foster internal mobility as a key element of our culture of employee growth and development, supported by a compensation philosophy that guarantees pay equity and fairness. Therefore, all compensation changes associated with an internal move will be reviewed by the Total Rewards & People Enablement team on a case by case basis.

The annual salary range for this full-time position is

$66,300—$149,150 USD

Benefits

Our full benefits & perks are explained in our handbook at remote.com/r/benefits. As a global company, each country works differently, but some benefits/perks are for all Remoters:

  • work from anywhere
  • flexible paid time off
  • flexible working hours (we are async)
  • 16 weeks paid parental leave
  • budget towards co-working spaces, learning and wellness (including gym memberships)
  • mental health support services
  • stock options
  • home office budget & IT equipment

How you’ll plan your day (and life)

We work async at Remote which means you can plan your schedule around your life (and not around meetings). Read more at remote.com/async.

You will be empowered to take ownership and be proactive. When in doubt you will default to action instead of waiting. Your life-work balance is important and you will be encouraged to put yourself and your family first, and fit work around your needs.

If that sounds like something you want, apply now!

How to apply

  1. Please fill out the form below and upload your CV with a PDF format.
  2. We kindly ask you to submit your application and CV in English, as this is the standardised language we use here at Remote.
  3. If you don’t have an up to date CV but you are still interested in talking to us, please feel free to add a copy of your LinkedIn profile instead.

Not only do we encourage folks from all ethnic groups, genders, sexuality, age, abilities, disability status and any other under-represented group to apply, but we prioritize a sense of belonging. We have 4 ERGs (Women, Disability, Queer, Minorities in Tech) who meet regularly with the People team. During your interviews and beyond, we ask & encourage anybody who needs an accommodation to request one from their recruiter.

We will ask you to voluntarily tell us your pronouns at interview stage, and you will have the option to answer our anonymous demographic questionnaire when you apply below. As an equal employment opportunity employer it’s important to us that our workforce reflects people of all backgrounds, identities, and experiences and this data will help us to stay accountable. We thank you for providing this data, if you chose to.

At Remote, we embrace AI as a valuable tool while prioritizing human creativity and authenticity. We look forward to meeting candidates who balance innovation with genuine expertise and experience. To learn more about Remote’s AI guidelines check see here.

Please note we accept applications on an ongoing basis.

Read the full description
Legal Counsel- Mortgage Loans (Hybrid Birmingham, AL) at Protective Life

Licensed attorney manages legal support for commercial mortgage loan investments, including loan closings, document review/drafting, compliance, and portfolio maintenance.

Senior Hybrid Posted 14 days ago RemoteFirstJobs Product
What this role involves

The work we do has an impact on millions of lives, and you can be a part of it.

We help protect our customers against life’s uncertainties. Regardless of where you work within the company, you’ll be helping provide protection and peace of mind when our customers need it most.

Basic Purpose and Objective of the Position:

This professional officer role is designed for a licensed attorney with substantial legal experience in commercial mortgage lending and related legal matters. The position is responsible for providing and managing legal support for the Company’s investment activities, including the review and drafting of loan commitments, the closing of new mortgage loans, compliance with regulatory requirements, and ongoing legal administration of the investment portfolio. The incumbent should have significant experience, typically five or more years, in commercial real estate lending and/or private practice with a specialization in this area. A strong commitment to quality, responsiveness, and customer service is essential to maintaining and strengthening long-term business relationships.

Key Responsibilities

•    New Mortgage Loan Closings. Ensure the Company’s mortgage loan investments are safeguarded through the preparation, review, analysis, negotiation and modification of the legal documents securing its investments.

•    Perform all legal work associated with the closing of the Company’s commercial mortgage loans including: drafting, negotiation and review of loan commitments, loan documents and other legal documents; review title commitments, survey and title policies for property serving as collateral; review due diligence materials to insure compliance with loan commitment requirements; and coordinate with outside counsel in all aspects of closing the Company’s loan commitments for commercial mortgage loans

•    Portfolio Maintenance. Ensure proper maintenance of the Company’s loan portfolio by providing timely legal documentation of changes to portfolio loans or the properties securing them (e.g. partial releases, consents to easements, replatting, loan modifications and loan assumptions).

•    Serve as Legal Advisor. Support and facilitate the decision-making process in the Investment Department. Act as legal advisor to the department. Assist and advise in development of policies and procedures to respond to regulatory and legislative requirements imposed as the Company and its investments

•    Manage and train one or more legal support staff (i.e. legal secretaries, legal assistants and paralegals).

•    Other Job Duties as assigned by senior management.

Knowledge/Experience/Education/Training:

•    This position requires an attorney with 5+ years of negotiating and legal drafting skills equivalent to a partner at a major law firm. A breadth of industry knowledge and contacts (both legal and business) are essential.

Abilities:

•    The incumbent will need meticulous attention to detail and negotiating stamina to protect and ensure the quality of the Company’s investments, but must couple those abilities with an attitude of building positive customer experiences and relationships.

Contact with others.

•    Must have strong negotiating skills coupled with a firm commitment to customer service and development of long-term business relationships. At least 50% of the incumbent’s time is spent in communication with outside customers, mortgage banker and brokers and counsel for the parties to the mortgage transactions.

•    The incumbent must be proactive and creative in finding legal solutions for the business and competitive needs of the Company, particularly relating to creative investment opportunities (e.g the participating loan program, loan pools, new real estate ownership and lending models).

$95,500 - $140,000 a year

Protective’s targeted salary range for this position is $95,500 to $140,000. Actual salaries may vary depending on factors, including but not limited to, job location, skills, and experience. The range listed is just one component of Protective’s total compensation package for employees.

This position also offers additional incentive opportunities through an annual incentive based on individual and Company performance.

#LI-VD1

IND123

Employee Benefits:

We aim to protect the wellbeing of our employees and their families with a broad benefits offering. In addition to offering comprehensive health, dental and vision insurance, we support emotional wellbeing through mental health benefits and an employee assistance program. Work/life balance is important and Protective offers a variety of paid time away benefits (e.g., paid time off, paid parental leave, short-term disability, and a cultural observance day). The financial health of our employees is just as important as physical and emotional health.  Some of the financial wellbeing benefits include contributions to healthcare accounts, a pension plan, and a 401(k) plan with Company matching. All employees are encouraged to protect their overall wellbeing by engaging in ProHealth Rewards, Protective’s platform to improve wellbeing while earning cash rewards.

Eligibility for certain benefits may vary by position in accordance with the terms of the Company’s benefit plans.

Accommodations for Applicants with a Disability:

If you require an accommodation to complete the application and recruitment process due to a disability, please email [email protected]. This information will be held in confidence and used only to determine an appropriate accommodation for the application and recruitment process.

Please note that the above email is solely for individuals with disabilities requesting an accommodation.  General employment questions should not be sent through this process.

We are proud to be an equal opportunity employer committed to being inclusive and attracting, retaining, and growing an inclusive workforce.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Read the full description
Legal Managing Counsel, Commercial (EMEA) at Remote

Senior lawyer handles commercial SaaS contracts, enterprise deals, and partnership agreements while supporting the EMEA sales team.

Senior Remote Posted 14 days ago RemoteFirstJobs Product
What this role involves

About Remote

Remote is solving modern organizations’ biggest challenge – navigating global employment compliantly with ease. We make it possible for businesses of all sizes to recruit, pay, and manage international teams. With our core values at heart and future focused work culture, our team works tirelessly on ambitious problems, asynchronously, around the world. You can find Remoters working from 6 different continents (Antarctica left to go!) and all of our positions are fully remote.

With Innovation as one of the core values, we have built Automation and AI capabilities into the requirements for every role.

We encourage every member of the Remote team to bring their talents, experiences and culture to the table to help us build the best-in-class HR platform.

If you are energetic, curious, motivated and ambitious, be part of our world. Apply now and define the future of work!

What this job can offer you

This is an exciting time to join Remote and make a personal difference in the global HR-tech space as Managing Counsel - Commercial. We are looking for a seasoned and business-oriented commercial lawyer who is interested in helping with our team’s mission, namely: to deliver pragmatic and innovative legal solutions for Remote’s products and stakeholders while protecting Remote from unacceptable risk. This role is a senior individual contributor role with no managerial responsibilities. It will be part of the Employment, Product and Commercial Legal sub-team.

As an independent senior lawyer, you will primarily support our global commercial deals, as well as supporting embedded partnerships, resell, and other channel arrangements. You will provide critical support for the EMEA sales team, tag-teaming with the existing EMEA sales and DP counsel to ensure seamless regional coverage.

Remote’s well established Legal team is a bunch of friendly, talented and highly motivated lawyers from a whole host of different countries with some awesome experiences, and we are looking for a great match for them.

What you bring

  • Proven expertise in supporting commercial transactions, particularly enterprise-level SaaS agreements, Terms of Service negotiations, and sales contract reviews. Experience supporting sales teams in EMEA is highly valued.
  • Partnership and channel/reseller agreement experience is a strong plus, as we anticipate needs in structuring and negotiating strategic partnerships.
  • Prior HR Tech industry experience or familiarity with bespoke HR services agreements is beneficial, though not required.
  • Solid commercial drafting skills are critical for this role, with the ability to craft clear, precise, and enforceable agreements that protect Remote’s interests while facilitating business objectives.
  • Strong negotiation skills with the ability to develop creative, practical solutions for complex commercial and business challenges.
  • Sharp commercial instincts and strategic thinking, with a focus on driving business success while effectively navigating legal complexities. You are commercially minded and comfortable letting go of immaterial points in contract negotiations to keep deals moving forward efficiently.
  • Strong working knowledge of data protection laws, especially GDPR, is essential for managing data flows. Prior background in U.S. data protection laws is also a plus.
  • Proven ability to excel in a fast-paced environment, maintaining responsiveness and adaptability under pressure (you can take the heat and keep moving forward).
  • Strong capacity to work independently while collaborating effectively with Sales, Finance, Product and other functional teams—you’re confident in your expertise but always open to learning, and you prioritize team success over personal ego.
  • Outstanding ability to build trusted relationships with GTM stakeholders while maintaining independent legal judgment.
  • You know when to be flexible and when to push back firmly on unreasonable requests, always acting as a strategic business partner rather than a bottleneck.
  • A healthy dose of humor and humility that makes you a joy to work with.
  • Demonstrates strong automation and AI capabilities and AI fluency.

Key Responsibilities

  • Act as the primary legal advisor to our EMEA sales teams, providing timely and practical legal support on Terms of Service negotiation, contract redlining, and commercial agreement reviews—always prioritizing responsiveness, brevity and clarity.
  • Provide additional legal support to AMER sales teams as needed, ensuring consistent and high-quality legal guidance across regions.
  • Strategize, draft and negotiate partnership agreements and channel/reseller agreements as opportunities arise, supporting our growing partnership initiatives.
  • Partner closely with Sales, Finance and other cross-functional teams to structure and review commercial agreements that align with business objectives while mitigating legal and operational risks.
  • Develop and improve templates, playbooks, processes and other knowledge resources around commercial transactions and sales support.
  • Provide legal training and guidance to internal stakeholders, particularly sales teams, to empower them with the tools and knowledge necessary to navigate complex commercial issues effectively.
  • Bring a solutions-focused mindset to every negotiation, minimizing roadblocks and resolving issues without unnecessary escalation.

Practicals

  • You’ll report to: Director, Legal - Commercial
  • Team: Legal - Commercial (Direct Sales & Partnerships)
  • Location: For this position we welcome everyone to apply, but we will prioritize applications from EMEA time zones, with AMER East Coast time zone as secondary preference
  • Start date: As soon as possible

Application process

  1. Interview with recruiter
  2. Interview with hiring manager
  3. Written exercise
  4. Interview with legal team and stakeholders
  5. Bar Raiser Interview
  6. Reference check
  7. Prior employment verification check

Remote’s Total Rewards philosophy is to ensure fair, unbiased compensation and fair equity pay along with competitive benefits in all locations in which we operate. We do not agree to or encourage cheap-labor practices and therefore we ensure to pay above in-location rates. We hope to inspire other companies to support global talent-hiring and bring local wealth to developing countries.

At first glance our salary bands seem quite wide - here is some context. At Remote we have international operations and a globally distributed workforce.  We use geo ranges to consider geographic pay differentials as part of our global compensation strategy to remain competitive in various markets while we hiring globally.

Our salary ranges are determined by role, level and location, and our job titles may span more than one career level. The actual base pay for the successful candidate in this role is dependent upon many factors such as location, transferable or job-related skills, work experience, relevant training, business needs, and market demands. The base salary range may be subject to change.

At Remote, we foster internal mobility as a key element of our culture of employee growth and development, supported by a compensation philosophy that guarantees pay equity and fairness. Therefore, all compensation changes associated with an internal move will be reviewed by the Total Rewards & People Enablement team on a case by case basis.

The annual salary range for this full-time position is

$66,300—$149,150 USD

Benefits

Our full benefits & perks are explained in our handbook at remote.com/r/benefits. As a global company, each country works differently, but some benefits/perks are for all Remoters:

  • work from anywhere
  • flexible paid time off
  • flexible working hours (we are async)
  • 16 weeks paid parental leave
  • budget towards co-working spaces, learning and wellness (including gym memberships)
  • mental health support services
  • stock options
  • home office budget & IT equipment

How you’ll plan your day (and life)

We work async at Remote which means you can plan your schedule around your life (and not around meetings). Read more at remote.com/async.

You will be empowered to take ownership and be proactive. When in doubt you will default to action instead of waiting. Your life-work balance is important and you will be encouraged to put yourself and your family first, and fit work around your needs.

If that sounds like something you want, apply now!

How to apply

  1. Please fill out the form below and upload your CV with a PDF format.
  2. We kindly ask you to submit your application and CV in English, as this is the standardised language we use here at Remote.
  3. If you don’t have an up to date CV but you are still interested in talking to us, please feel free to add a copy of your LinkedIn profile instead.

Not only do we encourage folks from all ethnic groups, genders, sexuality, age, abilities, disability status and any other under-represented group to apply, but we prioritize a sense of belonging. We have 4 ERGs (Women, Disability, Queer, Minorities in Tech) who meet regularly with the People team. During your interviews and beyond, we ask & encourage anybody who needs an accommodation to request one from their recruiter.

We will ask you to voluntarily tell us your pronouns at interview stage, and you will have the option to answer our anonymous demographic questionnaire when you apply below. As an equal employment opportunity employer it’s important to us that our workforce reflects people of all backgrounds, identities, and experiences and this data will help us to stay accountable. We thank you for providing this data, if you chose to.

At Remote, we embrace AI as a valuable tool while prioritizing human creativity and authenticity. We look forward to meeting candidates who balance innovation with genuine expertise and experience. To learn more about Remote’s AI guidelines check see here.

Please note we accept applications on an ongoing basis.

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Legal Litigation Lawyer - Fully Remote | Upto $160/hr

Litigation lawyer handles legal disputes and courtroom representation for clients, working fully remote with flexible hourly rates up to $160/hr.

Senior Remote Posted 14 days ago Himalayas
What this role involves
About the jobMercor connects elite creative and technical talent with leading AI research labs.
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Legal Consultant, Legal Technology Consulting - Enterprise Legal Management at Harbor.ai

Senior consultant advises corporate legal clients on enterprise legal management technology selection, implementation, and optimization while managing project lifecycles and requirements.

Senior Remote Posted 15 days ago RemoteFirstJobs Product
What this role involves

Harbor is seeking a Senior Consultant- ELM (Enterprise Legal Management) to join our dynamic Legal Technology & Operations – Corporate Legal Technology team. Our team is at the forefront of innovation and delivery for our corporate legal department clients, with deep experience in evaluating legal processes and technology, developing technology roadmaps, system selection and implementation, and change management. We work with leading vendors allowing clients to benefit from our product-specific expertise and market perspective. We serve both as advisors and as experienced, scalable hands-on resources, collaborating with our clients to contain risk and cost through operational improvement, efficient data management, and technology usage.

As a part of the Corporate Legal Technology Team, we will rely on you to work closely with Harbor project team members and clients to lead requirements gathering and analysis, executing against legal technology best practices, and leveraging our methodologies to facilitate the selection, implementation and/or optimization of legal technology systems and tools leveraged by our corporate law department clients. As a Senior Consultant, you will be expected to work with senior and junior-level internal resources, to help manage the project lifecycle.  This is a full-time, remote position that can be worked from anywhere in the US or Canada.

Job Duties and Responsibilities:

  • Leverage industry knowledge, organizational skills, and project management experience to support all aspects of projects including facilitating requirements gathering, preparing documentation of processes, and helping to implement identified solutions
  • Support client business process review, identify key client business requirements and support transformation of business requirements to technical requirements and design
  • Draft deliverables during a project lifecycle including findings and recommendations, functional and technical design documents, data maps, test scripts, training and communication plans, training guides.
  • Configure and develop technologies based on technical requirements and design
  • Administer system testing, track defects, and collaborate with technology providers and clients to resolve defects (on technology related projects)
  • Assist with management of project scope, schedules, workplans, timelines, and budgets
  • Manage client expectations and project scope, communicating directly with clients to continually foster relationships
  • Become proficient in specific legal technologies related to active projects
  • Research and stay abreast of legal industry and technology trends, product developments, best practices, emerging technologies and the use of AI
  • Assist in business development efforts such as proposals, workplans, and presentations
  • Seek opportunities to proactively contribute to the growth and development of the Corporate Legal Technology team and Harbor

Experience, Education and Other Qualifications:

  • 3+ years of relevant experience in the legal or consulting industry (i.e., in-house legal department, law firm, legal software provider, consulting firm)
  • 3+ years experience in legal technology contributing to assessments, requirements gathering, system design, configuration, implementation, testing and deployment, with experience implementing ELM/eBilling + Matter Management, Legal Hold, and Legal Workflow tools.
  • Experience with TeamConnect, CounselLink is preferred, also WK T360, Onit/SimpleLegal, Litify, Legal Tracker, Brightflag, doeLegal, and similar systems; this experience should include related data migration and integration workstreams
  • Four- year degree in Finance, Business, Computer Science, Software Engineering, Information Science, Economics, Statistics, Accounting, Data & Analytics, and the like, or equivalent combination of experience and education
  • Understanding of the implementation process including requirement analysis, design, configuration/development, migration, testing, and change management
  • Strong observational, analytical, numerical reasoning, business acumen, problem solving and leadership skills; proficient in process mapping
  • Effective communication and storytelling skills (written and spoken) and a client service-centric mindset
  • Strong organizational skills with the ability to work on multiple projects simultaneously, prioritize tasks, maintaining exacting standards for work product and attention to detail
  • Project management experience, including managing tasks, resources, and financials on various stages of technology implementation projects
  • Excels in a cooperative team environment; takes initiative to forward team operational efficiency through improved methodologies; able to ideate and create client deliverables with moderate oversight
  • Positive, enthusiastic attitude and entrepreneurial spirit with an eagerness to quickly learn and develop new subject matter expertise and business skills
  • Advanced computer skills (primarily Excel, Word, PowerPoint, and Visio); familiarity with use of Outlook, Teams and SharePoint as collaboration tools

About Us:

Harbor is the preeminent provider of expert services across strategy, legal technology, operations, and intelligence. Our globally integrated team of 900+ strategists, technologists, and specialists navigate alongside our clients – leading law firms, corporations, and their law departments – to provide essential resources and invaluable insights. Anchored in a rich heritage of deep knowledge, steadfast relationships, and mutual respect, our unwavering dedication lies in shaping the future of the legal industry and fostering enduring partnerships within our community and ecosystem.

Harbor is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, marital status, civil union status, national origin, ancestry, age, parental status, disabled status, veteran status, or any other legally protected classification, in accordance with applicable law.

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Legal Consultant, Legal Technology Consulting - Enterprise Legal Management at Harbor.ai

Senior consultant advises corporate legal clients on enterprise legal management technology selection, implementation, and optimization while managing project lifecycle and change management.

Senior Remote Posted 15 days ago RemoteFirstJobs Product
What this role involves

Harbor is seeking a Senior Consultant- ELM (Enterprise Legal Management) to join our dynamic Legal Technology & Operations – Corporate Legal Technology team. Our team is at the forefront of innovation and delivery for our corporate legal department clients, with deep experience in evaluating legal processes and technology, developing technology roadmaps, system selection and implementation, and change management. We work with leading vendors allowing clients to benefit from our product-specific expertise and market perspective. We serve both as advisors and as experienced, scalable hands-on resources, collaborating with our clients to contain risk and cost through operational improvement, efficient data management, and technology usage.

As a part of the Corporate Legal Technology Team, we will rely on you to work closely with Harbor project team members and clients to lead requirements gathering and analysis, executing against legal technology best practices, and leveraging our methodologies to facilitate the selection, implementation and/or optimization of legal technology systems and tools leveraged by our corporate law department clients. As a Senior Consultant, you will be expected to work with senior and junior-level internal resources, to help manage the project lifecycle.  This is a full-time, remote position that can be worked from anywhere in the US or Canada.

Job Duties and Responsibilities:

  • Leverage industry knowledge, organizational skills, and project management experience to support all aspects of projects including facilitating requirements gathering, preparing documentation of processes, and helping to implement identified solutions
  • Support client business process review, identify key client business requirements and support transformation of business requirements to technical requirements and design
  • Draft deliverables during a project lifecycle including findings and recommendations, functional and technical design documents, data maps, test scripts, training and communication plans, training guides.
  • Configure and develop technologies based on technical requirements and design
  • Administer system testing, track defects, and collaborate with technology providers and clients to resolve defects (on technology related projects)
  • Assist with management of project scope, schedules, workplans, timelines, and budgets
  • Manage client expectations and project scope, communicating directly with clients to continually foster relationships
  • Become proficient in specific legal technologies related to active projects
  • Research and stay abreast of legal industry and technology trends, product developments, best practices, emerging technologies and the use of AI
  • Assist in business development efforts such as proposals, workplans, and presentations
  • Seek opportunities to proactively contribute to the growth and development of the Corporate Legal Technology team and Harbor

Experience, Education and Other Qualifications:

  • 3+ years of relevant experience in the legal or consulting industry (i.e., in-house legal department, law firm, legal software provider, consulting firm)
  • 3+ years experience in legal technology contributing to assessments, requirements gathering, system design, configuration, implementation, testing and deployment, with experience implementing ELM/eBilling + Matter Management, Legal Hold, and Legal Workflow tools.
  • Experience with TeamConnect, CounselLink is preferred, also WK T360, Onit/SimpleLegal, Litify, Legal Tracker, Brightflag, doeLegal, and similar systems; this experience should include related data migration and integration workstreams
  • Four- year degree in Finance, Business, Computer Science, Software Engineering, Information Science, Economics, Statistics, Accounting, Data & Analytics, and the like, or equivalent combination of experience and education
  • Understanding of the implementation process including requirement analysis, design, configuration/development, migration, testing, and change management
  • Strong observational, analytical, numerical reasoning, business acumen, problem solving and leadership skills; proficient in process mapping
  • Effective communication and storytelling skills (written and spoken) and a client service-centric mindset
  • Strong organizational skills with the ability to work on multiple projects simultaneously, prioritize tasks, maintaining exacting standards for work product and attention to detail
  • Project management experience, including managing tasks, resources, and financials on various stages of technology implementation projects
  • Excels in a cooperative team environment; takes initiative to forward team operational efficiency through improved methodologies; able to ideate and create client deliverables with moderate oversight
  • Positive, enthusiastic attitude and entrepreneurial spirit with an eagerness to quickly learn and develop new subject matter expertise and business skills
  • Advanced computer skills (primarily Excel, Word, PowerPoint, and Visio); familiarity with use of Outlook, Teams and SharePoint as collaboration tools

About Us:

Harbor is the preeminent provider of expert services across strategy, legal technology, operations, and intelligence. Our globally integrated team of 900+ strategists, technologists, and specialists navigate alongside our clients – leading law firms, corporations, and their law departments – to provide essential resources and invaluable insights. Anchored in a rich heritage of deep knowledge, steadfast relationships, and mutual respect, our unwavering dedication lies in shaping the future of the legal industry and fostering enduring partnerships within our community and ecosystem.

Harbor is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, marital status, civil union status, national origin, ancestry, age, parental status, disabled status, veteran status, or any other legally protected classification, in accordance with applicable law.

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Legal Associate Director, Regulatory Affairs Strategy at Immunovant

Develops and executes regulatory strategies for clinical drug development, manages FDA submissions and health authority interactions, and mentors regulatory team members.

Senior Posted 15 days ago RemoteFirstJobs Product
What this role involves

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.

Organizational Overview:

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.

The Role:

This highly dynamic team is seeking a motivated and entrepreneurial Associate Director, Regulatory Affairs Strategy, to play a key role on our cross-functional R&D team. In this role, you will be responsible for supporting and contribute to innovative global regulatory strategies that expedite development, maximize the probability of success, identify regulatory opportunities, and mitigate risks. The individual in this position will have the unique opportunity to grow and mentor regulatory scientists on regulatory requirements and regulatory environmental trends, as well as help shape the regulatory approach in a rapid-growth biotech startup.

Key Responsibilities:

  • Support and contribute to regulatory strategies that expedite development and maximize the probability of success based on knowledge of regulatory environment.
  • Help mitigate identified regulatory risks.
  • Understand global regulatory requirements to support strategy.
  • Collaborate to ensure regulatory strategy is understood by project teams.
  • Play a hands-on role in planning, preparing, and coordinating regulatory documents for submission to global health authorities in support of regulatory filings, such as INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual updates, briefing documents, and responses to Agency queries.
  • Close collaboration with internal and external cross-functional team members to ensure the achievement of submissions and timely approvals of applications.
  • Support interactions with FDA and other Health Authorities.
  • Help formulate communications of project updates and risks to senior management and stakeholders across the organization.
  • Track regulatory commitments, deliverables, and overall project timelines.
  • Maintain up-to-date knowledge and understanding of global regulatory requirements.
  • Contribute to the development of policies and procedures in alignment with GxPs, global regulatory requirements and guidance, and corporate objectives.
  • Provide hands-on support to cross-functional teams in planning, preparing, and coordinating documents for submission to global authorities in support of regulatory filings, such as INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual updates, briefing documents, and responses to Agency queries.

Requirements:

  • 8+ years of biopharmaceutical experience, which includes at least 4 years of direct experience in Regulatory Affairs.
  • An advanced degree (Master’s) in a relevant scientific discipline is preferred.
  • Experience in biologics or small molecule drug development, parenteral products, including combination products, and orphan/rare disease product development.
  • Experience in supporting and implementing regulatory strategies in a global environment.
  • Comprehensive understanding of applicable global regulations, guidance, and practices.
  • Demonstrated hands-on experience in the preparation and submission of global regulatory documents, including clinical trial applications and maintenance (IND/CTA), NDA/BLA/MAA, briefing documents, Clinical Trial Applications, and Agency queries.
  • Prior experience in supporting interactions with FDA and other global regulatory authorities.
  • Excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
  • Ability to problem-solve regulatory issues and apply learnings.
  • Works collaboratively and efficiently with multiple functional areas in a fast-paced matrixed team environment, including functional team members, company management, and external vendors and contract organizations.
  • Strong team and project management skills
  • Strong verbal and written communication skills.
  • Results-oriented individual with a strong work ethic and ability to complete projects with oversight.
  • Knowledge of GxP, ICH, FDA, EMA, and other global regulations and guidance.
  • Attention to detail and an ability to balance analytical and critical-thinking skills to support data-driven, strategically oriented regulatory proposals and documents.
  • Experience supporting regulatory strategies for biologics and/or rare disease development programs.
  • Commitment to company values and culture.
  • Proven ability to adapt to change and uncertainty as projects evolve.
  • Self-motivated, with initiative and the ability to take ownership of and follow through with specific tasks.
  • Ability to multi-task and adjust priorities quickly while working under tight deadlines.
  • Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint, Project).

Work Environment:

  • Remote-based
  • Dynamic, interactive, fast-paced, and entrepreneurial environment
  • Domestic or international travel is required (10-20%)

Salary range for posting

$185,000—$190,000 USD

Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave.

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Legal Regulatory Attorney - Fully Remote | Upto $100/hr

Regulatory attorney advises on compliance, regulatory requirements, and legal matters for AI research operations.

Senior Remote Posted 18 days ago Himalayas
What this role involves
About the jobMercor connects elite creative and technical talent with leading AI research labs.
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Legal Corporate Law Expert - M&A Specialist

Provides expert legal counsel on mergers and acquisitions transactions for AI research organizations.

Senior Remote Posted 18 days ago Himalayas
What this role involves
About the jobMercor connects elite creative and technical talent with leading AI research labs.
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Legal Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device (Hybrid) at AbbVie

Develops and implements US/Canada regulatory strategy for aesthetics device products, managing FDA interactions and ensuring compliance throughout the product lifecycle.

Senior Hybrid Posted 19 days ago RemoteFirstJobs Product
What this role involves

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. This individual demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements. They assure that regulatory strategies defined within the Global Regulatory Product Team (GRPT), are effectively implemented and maintained in line with changing regulatory and business needs. This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured, or distributed to meet relevant US and Canada regulatory requirements.

Responsibilities:

  • This individual has responsibility for products/multiple driver indications for a product within a Therapeutic Area and supports the Global Regulatory Lead (GRL), in the development & execution of the regulatory strategy.  Area of responsibility has significant regulatory impact and possibly significant impact to AbbVie overall.
  • Leads total product lifecycle activities, including product/manufacturing change assessments, post-approval requirements, addressing Health Authority information requests, annual reporting, and internal regulatory requests among others, providing business-critical decision and strategy support.
  • Manages interface with Health Authority (FDA) for key projects/issues, including direct collaboration with review division personnel.  May also serve as primary liaison and interface with FDA for meetings, teleconferences and coordinates preparation of FDA meeting briefing packages and responses.
  • Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.
  • Operates independently, with recognition of when to consult management.  Makes decisions and plans for operations (workflow, assignments) within area of responsibility with minimal direction.
  • Coordinates, prepares and/or supervises the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review.  Ensures application of established policies and best practice regulatory standards for all US/Canada product registrations.
  • Demonstrates understanding of current US and Canada regulations and guidance, political and legal climate and industry practices to assist in meeting organizational goals.  Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
  • Presents pertinent regulatory information to appropriate cross-functional teams.
  • Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).

Qualifications

Minimum Qualifications:

  • Advanced degree (e.g. PharmD, PhD, MS) or Regulatory certification
  • 5+ years Regulatory, R&D, or equivalent industry-related experience.
  • Experience in medical device space
  • Experience with digital health/software
  • Proven skill at implementing successful affiliate regulatory strategies (US or Canada experience preferred).
  • Experience working in a complex and matrix environment.
  • Experience interfacing with government regulatory agencies.

Preferred Qualifications:

  • Preferred: Advanced Degree and/or Certifications or direct experience with pharmaceutical regulatory activities
  • Global regulatory experience is a plus.

Other Required Skills:

  • Demonstrates excellent negotiation skills, problem solving skills and builds consensus.
  • Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization.
  • Able to deliver challenging messages effectively without compromising important business relationships.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​
  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
  • This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

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