Senior Level Regulatory Affairs Analyst Jobs
Senior level regulatory affairs analyst jobs place experienced professionals in charge of regulatory strategy, submission ownership, and the cross-functional teams or workflows that deliver compliance outcomes. Openings are concentrated across Biotechnology & Pharmaceuticals, Medical Devices, and Healthcare & Medical Services, with a mix of on-site, remote, and hybrid roles available, and employers like Revolution Medicines, Revolution Medicines, and Insmed Incorporated hiring at this level now.
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Showing 5 of 161+ Senior Level Regulatory Affairs Analyst jobs
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
Career development with an international company where you can grow the career you dream of
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year
An excellent retirement savings plan with high employer contribution
Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists
The Opportunity
The Director, Regulatory Affairs provides leadership, direction and support for regulatory policy and cross-business regulatory initiatives within the company, actively influencing changing regulations and guidance affecting the company through participation on trade associations and interfaces with regulatory agencies. This person will direct activities associated with capturing domestic and international information both internal and external that impacts the quality, regulatory, and compliance areas of Abbott and keep management abreast of regulatory changes and the impact they could have on the organization.
Also, this person will direct and manage cross-business regulatory activities designed to address emerging regulatory issues, incorporate strategic action, and advance the development of Abbott regulatory professionals. This person will be a subject matter expert in the regulatory area organization and serve as a resource that others within the organization can approach for guidance.
What You’ll Work On
Regulatory Intelligence:
- Gather, assess, summarize, and disseminate available regulatory information, such as proposed rules and guidance
- Develop in conjunction with relevant internal stakeholders, draft, and submit directly to regulatory agencies and trade associations the Abbott position/response to proposed device regulatory policy
- Implement processes for monitoring and communicating emerging regulatory issues
Cross-Business Initiatives:
- Lead cross-business regulatory council consisting of business regulatory heads, legal, government affairs, and AQR
- Chair or co-chair council committees designed to execute objectives defined by the regulatory council, such as global conference, emerging issues, talent management
- Work across businesses, government affairs, and legal to define, develop, and obtain consensus on Abbott regulatory positions on critical regulatory proposals
- Develop and maintain communication strategies for efficient and effective means of cross business information sharing
Strategic Planning:
- Anticipate regulatory emerging issues and develop solutions to them
- Identify need for new regulatory policies/processes
- Develop solutions to address emerging regulatory issues with other members of management and stakeholders
- Develop corporate positions on regulatory risk-benefit
- Create and develop positions and strategies based upon proposed regulatory requirements
Influence:
- Identify for stakeholders new regulatory requirements to ensure company-wide compliance
- Advance the organization’s position by participating and taking leadership roles in professional associations, industry and trade groups and appropriate standards organizations
- Advise management and stakeholders on regulatory issues
- Manage communication and negotiation with regulatory authorities and lobbying government leaders
- Utilize expert technical regulatory skills to influence regulators on complex issues
- Consult with and advise businesses on regulatory issues
- Participate in the development of new regulations, guidelines and/or standards to promote scientific innovation balanced with appropriate safety concerns
Supervisory / Management Responsibilities
- Provides leadership without direct authority (i.e., project leader); includes 1 direct report
Position Accountability / Scope
- Corporate-wide strategies and programs
- External and internal regulatory advocacy
- Recognized as a key opinion leader and resource in regulatory affairs
- Develops, communicates, and builds consensus for goals that are in alignment with the corporation.
- Provides leadership by communicating and providing guidance towards achieving cross-business and/or corporate objectives.
- Interfaces with a variety of management levels including senior management on significant matters, often requiring the coordination of activity across organizational units.
- Leads multiple cross-business committees/teams
- Acts as a mentor to less-experienced staff internal and external to the department/division.
- Exercises judgment independently.
Required Qualifications
- Bachelor's degree
- 7-10 years of experience in a regulated industry (e.g., medical device, pharmaceutical, nutritional/food products)
- Knowledge of how agency regulations and guidance are developed
- Negotiate internally and externally with regulatory agencies
- Work with cross-functional teams
- Demonstrated analytical, strategic-thinking, and problem-solving skills
- Communicate effectively verbally and in writing to diverse audiences and personnel
- Write and edit regulatory documents; persuasive writing
- Ability to prepare and present written and oral reports and other presentations to internal and external audiences, including senior management and regulatory agencies
- Able to juggle multiple and competing priorities
Preferred Qualifications
- Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields
- Advanced degree (MS in technical area, PhD, Law)
- 7-10 years of experience in regulatory preferred, but may consider quality assurance, research and development/support, scientific affairs, operations, or related area
APPLY NOW
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal
The base pay for this position is $171,300.00 – $342,700.00. In specific locations, the pay range may vary from the range posted.
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
Career development with an international company where you can grow the career you dream of
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year
An excellent retirement savings plan with high employer contribution
Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists
The Opportunity
The Director, Regulatory Affairs provides leadership, direction and support for regulatory policy and cross-business regulatory initiatives within the company, actively influencing changing regulations and guidance affecting the company through participation on trade associations and interfaces with regulatory agencies. This person will direct activities associated with capturing domestic and international information both internal and external that impacts the quality, regulatory, and compliance areas of Abbott and keep management abreast of regulatory changes and the impact they could have on the organization.
Also, this person will direct and manage cross-business regulatory activities designed to address emerging regulatory issues, incorporate strategic action, and advance the development of Abbott regulatory professionals. This person will be a subject matter expert in the regulatory area organization and serve as a resource that others within the organization can approach for guidance.
What You’ll Work On
Regulatory Intelligence:
- Gather, assess, summarize, and disseminate available regulatory information, such as proposed rules and guidance
- Develop in conjunction with relevant internal stakeholders, draft, and submit directly to regulatory agencies and trade associations the Abbott position/response to proposed device regulatory policy
- Implement processes for monitoring and communicating emerging regulatory issues
Cross-Business Initiatives:
- Lead cross-business regulatory council consisting of business regulatory heads, legal, government affairs, and AQR
- Chair or co-chair council committees designed to execute objectives defined by the regulatory council, such as global conference, emerging issues, talent management
- Work across businesses, government affairs, and legal to define, develop, and obtain consensus on Abbott regulatory positions on critical regulatory proposals
- Develop and maintain communication strategies for efficient and effective means of cross business information sharing
Strategic Planning:
- Anticipate regulatory emerging issues and develop solutions to them
- Identify need for new regulatory policies/processes
- Develop solutions to address emerging regulatory issues with other members of management and stakeholders
- Develop corporate positions on regulatory risk-benefit
- Create and develop positions and strategies based upon proposed regulatory requirements
Influence:
- Identify for stakeholders new regulatory requirements to ensure company-wide compliance
- Advance the organization’s position by participating and taking leadership roles in professional associations, industry and trade groups and appropriate standards organizations
- Advise management and stakeholders on regulatory issues
- Manage communication and negotiation with regulatory authorities and lobbying government leaders
- Utilize expert technical regulatory skills to influence regulators on complex issues
- Consult with and advise businesses on regulatory issues
- Participate in the development of new regulations, guidelines and/or standards to promote scientific innovation balanced with appropriate safety concerns
Supervisory / Management Responsibilities
- Provides leadership without direct authority (i.e., project leader); includes 1 direct report
Position Accountability / Scope
- Corporate-wide strategies and programs
- External and internal regulatory advocacy
- Recognized as a key opinion leader and resource in regulatory affairs
- Develops, communicates, and builds consensus for goals that are in alignment with the corporation.
- Provides leadership by communicating and providing guidance towards achieving cross-business and/or corporate objectives.
- Interfaces with a variety of management levels including senior management on significant matters, often requiring the coordination of activity across organizational units.
- Leads multiple cross-business committees/teams
- Acts as a mentor to less-experienced staff internal and external to the department/division.
- Exercises judgment independently.
Required Qualifications
- Bachelor's degree
- 7-10 years of experience in a regulated industry (e.g., medical device, pharmaceutical, nutritional/food products)
- Knowledge of how agency regulations and guidance are developed
- Negotiate internally and externally with regulatory agencies
- Work with cross-functional teams
- Demonstrated analytical, strategic-thinking, and problem-solving skills
- Communicate effectively verbally and in writing to diverse audiences and personnel
- Write and edit regulatory documents; persuasive writing
- Ability to prepare and present written and oral reports and other presentations to internal and external audiences, including senior management and regulatory agencies
- Able to juggle multiple and competing priorities
Preferred Qualifications
- Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields
- Advanced degree (MS in technical area, PhD, Law)
- 7-10 years of experience in regulatory preferred, but may consider quality assurance, research and development/support, scientific affairs, operations, or related area
APPLY NOW
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal
The base pay for this position is $171,300.00 – $342,700.00. In specific locations, the pay range may vary from the range posted.
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Find JobsSenior Level Regulatory Affairs Analyst Job Market
Who's Hiring
- Revolution Medicines25
- Insmed Incorporated5
- Azurity Pharmaceuticals4
- Eli Lilly3
Top Industries Hiring
- Biotechnology & Pharmaceuticals90
- Medical Devices11
- Healthcare & Medical Services11
- Science & Research10
- Technology & Software8
Senior Level Regulatory Affairs Analyst Jobs: Frequently Asked Questions
How do I get a senior level regulatory affairs analyst job?
Employers at this level want demonstrated ownership of regulatory submissions, such as NDAs, 510(k)s, or BLAs, not just support work. Candidates who stand out show they have led agency interactions, resolved complex compliance issues independently, and mentored junior analysts. A strong submission portfolio, deep familiarity with relevant guidance documents, and experience coordinating across legal, clinical, and manufacturing teams will carry more weight than credentials alone.
Which companies hire senior level regulatory affairs analysts?
Companies hiring senior level regulatory affairs analysts right now include Revolution Medicines, Revolution Medicines, and Insmed Incorporated, based on current listings on Migrate Mate as of July 2026. Hiring at this level comes primarily from large pharmaceutical, medical device, and biotech companies, as well as contract research organizations and regulatory consulting firms that staff experienced professionals on complex client engagements.
Are there remote senior level regulatory affairs analyst jobs?
Yes, though availability varies by employer and therapeutic area. About 38% of senior level regulatory affairs analyst openings are remote or hybrid as of July 2026, reflecting the document-driven and cross-functional nature of this work. Roles tied to manufacturing sites or requiring frequent in-person agency meetings are more likely to require on-site presence, while submission-focused and consulting roles often offer greater flexibility.
What makes a regulatory affairs analyst role senior level?
Senior level roles are defined by independent ownership rather than task execution. A senior regulatory affairs analyst leads submission strategy, owns relationships with regulatory agencies, and is accountable for outcomes, not just deliverables. These roles typically involve scoping regulatory pathways for new products, resolving complex agency questions, and mentoring or directing junior analysts. The expectation is that you bring judgment, not just process knowledge.
Which industries hire the most senior level regulatory affairs analysts?
Senior Level regulatory affairs analyst roles concentrate in Biotechnology & Pharmaceuticals, Medical Devices, and Healthcare & Medical Services, based on current listings on Migrate Mate as of July 2026. These sectors drive demand because they operate under rigorous federal oversight, require ongoing submissions throughout a product's lifecycle, and need experienced analysts who can navigate evolving agency expectations without close supervision.