Regulatory Affairs Specialist Jobs in New Jersey
Regulatory affairs specialist jobs in New Jersey sit at the center of one of the country's most active pharmaceutical and life sciences markets, with demand concentrated in drug development, medical devices, and biologics at every level from entry-level associate to senior director. The densest hiring is in and around Princeton, Parsippany, and the Raritan Valley corridor, where established employers like Johnson & Johnson, Merck, and Bristol Myers Squibb maintain large regulatory functions. The most consistently sought specialties are submissions and CMC regulatory writing, quality systems compliance, and FDA liaison roles. Find a role that fits below and apply directly.
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Showing 5 of 56+ Regulatory Affairs Specialist jobs
Job title: Senior Manager, Regulatory Affairs Advertising and Promotion
Location: Morristown, NJ/Cambridge, MA
About the job
As the Senior Manager, Regulatory Affairs Advertising and Promotion within our GRA Advertising and Promo Team, you will be responsible for conducting the independent review of advertising, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns. Ready to get started?
Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.
With some direction from the Therapeutic Area Head, will conduct the independent review of advertising, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns, including serving as regulatory lead for product launches. As the product A&P expert, contribute to the development and implementation of regulatory strategies for labeling, product defense, and development projects. Serve as the primary liaison with FDA, for assigned products, on matters related to advertising and promotional compliance matters.
About Sanofi
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
Main Responsibilities:
Identifies product-specific or therapeutic area A&P issues and works with other teams to propose and implement solutions.
Identifies different strategies for addressing issues; advises of risk/benefit of each and assists clients with making sound business decisions with the understanding of the potential risk/benefits with respect to intervening regulatory matters.
Oversees and bears responsibility for the successful implementation of regulatory strategic objectives and projects with minimal supervision.
Active participant and Regulatory representative on brand teams and Review Committees (RC) for commercial and medical materials, respectively.
Provides guidance and feedback to internal Sanofi constituencies (commercial groups, R&D) to maximize the competitive impact of product development as well as ultimate promotion, advertising, and reimbursement. Provides input to the Global organization on domestic regulatory strategies for in-line products through life cycle management programs.
Contribute A&P expertise to the development of optimal labeling on new and supplemental new drug applications.
Provides product-specific Regulatory strategies to mitigate risk; works in conjunction with brand team management to provide advice and risk/benefit analysis to maximize value to stakeholders.
Performs other duties as assigned.
About You
Basic Qualifications:
Bachelor’s degree from an accredited four-year college or university; Science focus preferred, but not require
Work Experience Required:
3+ Years experience within pharmaceutical or medical device advertising and promotional review.
Successful track record with relevant regulatory experience.
Dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing etc.
Knowledge, Skills and Equivalent Experience:
Knowledge and understanding of complex medical and scientific subject matter.
Ability to work well within cross-functional teams.
Demonstrates solid oral communication and writing skills.
Understanding of the U.S. pharmaceutical marketplace, and familiarity with medical terminology.
Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution.
Develops collaborative relationships to facilitate the accomplishment of work goals.
Develops and proposes innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities.
Shows ability to use appropriate interpersonal styles and techniques to gain acceptance of ideas or plans.
Can build collaborative internal networks to obtain cooperation.
Unquestionable ethics, professional integrity and personal values consistent with the Sanofi values.
Is able to balance projects with day-to-day duties, ensuring participation from other members of the department as needed.
Is able to establish priorities and timelines to effectively manage workload. Is able to multi-task well.
Deals with people in an honest and forthright manner representing information and data accurately.
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
Help improve the lives of millions of people globally by making drug development quicker and more effective.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#GD-SA #LI-SA
#LI-Hybrid
#vhd
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Job title: Senior Manager, Regulatory Affairs Advertising and Promotion
Location: Morristown, NJ/Cambridge, MA
About the job
As the Senior Manager, Regulatory Affairs Advertising and Promotion within our GRA Advertising and Promo Team, you will be responsible for conducting the independent review of advertising, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns. Ready to get started?
Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.
With some direction from the Therapeutic Area Head, will conduct the independent review of advertising, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns, including serving as regulatory lead for product launches. As the product A&P expert, contribute to the development and implementation of regulatory strategies for labeling, product defense, and development projects. Serve as the primary liaison with FDA, for assigned products, on matters related to advertising and promotional compliance matters.
About Sanofi
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
Main Responsibilities:
Identifies product-specific or therapeutic area A&P issues and works with other teams to propose and implement solutions.
Identifies different strategies for addressing issues; advises of risk/benefit of each and assists clients with making sound business decisions with the understanding of the potential risk/benefits with respect to intervening regulatory matters.
Oversees and bears responsibility for the successful implementation of regulatory strategic objectives and projects with minimal supervision.
Active participant and Regulatory representative on brand teams and Review Committees (RC) for commercial and medical materials, respectively.
Provides guidance and feedback to internal Sanofi constituencies (commercial groups, R&D) to maximize the competitive impact of product development as well as ultimate promotion, advertising, and reimbursement. Provides input to the Global organization on domestic regulatory strategies for in-line products through life cycle management programs.
Contribute A&P expertise to the development of optimal labeling on new and supplemental new drug applications.
Provides product-specific Regulatory strategies to mitigate risk; works in conjunction with brand team management to provide advice and risk/benefit analysis to maximize value to stakeholders.
Performs other duties as assigned.
About You
Basic Qualifications:
Bachelor’s degree from an accredited four-year college or university; Science focus preferred, but not require
Work Experience Required:
3+ Years experience within pharmaceutical or medical device advertising and promotional review.
Successful track record with relevant regulatory experience.
Dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing etc.
Knowledge, Skills and Equivalent Experience:
Knowledge and understanding of complex medical and scientific subject matter.
Ability to work well within cross-functional teams.
Demonstrates solid oral communication and writing skills.
Understanding of the U.S. pharmaceutical marketplace, and familiarity with medical terminology.
Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution.
Develops collaborative relationships to facilitate the accomplishment of work goals.
Develops and proposes innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities.
Shows ability to use appropriate interpersonal styles and techniques to gain acceptance of ideas or plans.
Can build collaborative internal networks to obtain cooperation.
Unquestionable ethics, professional integrity and personal values consistent with the Sanofi values.
Is able to balance projects with day-to-day duties, ensuring participation from other members of the department as needed.
Is able to establish priorities and timelines to effectively manage workload. Is able to multi-task well.
Deals with people in an honest and forthright manner representing information and data accurately.
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
Help improve the lives of millions of people globally by making drug development quicker and more effective.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#GD-SA #LI-SA
#LI-Hybrid
#vhd
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
See All 56 Regulatory Affairs Specialist Jobs in New Jersey
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Find JobsRegulatory Affairs Specialist Jobs by City in New Jersey
Where New Jersey roles are concentrated, by current openings.
Regulatory Affairs Specialist Job Market in New Jersey
A snapshot from current New Jersey openings, updated as new roles post.
Who's Hiring
Top Industries Hiring
- Biotechnology & Pharmaceuticals
- Healthcare & Medical Services
What New Jersey Employers Look For
The qualifications that appear most often in regulatory affairs specialist jobs across New Jersey.
- Bachelor's degree in life sciences, pharmacy, chemistry, or a related scientific field required
- Working knowledge of FDA regulations including 21 CFR Parts 210, 211, and 820
- Experience preparing and submitting INDs, NDAs, BLAs, or 510(k) submissions to FDA
- Familiarity with ICH guidelines and global regulatory submission formats such as eCTD
- RAC certification from the Regulatory Affairs Professionals Society preferred by most employers
- Proficiency with document management systems and regulatory information management platforms
Regulatory Affairs Specialist Jobs in New Jersey: Frequently Asked Questions
How do you become a regulatory affairs specialist in New Jersey?
New Jersey does not require a state-issued license to work as a regulatory affairs specialist, so the path runs through education and industry credentials. Most employers in the state's pharmaceutical and medical device corridor hire candidates with a bachelor's degree in a life science or related field. Gaining experience in quality assurance, clinical operations, or a laboratory role at a New Jersey biotech or pharma company is the most common entry route, and earning the RAC credential from the Regulatory Affairs Professionals Society strengthens a candidate's profile significantly.
How much do regulatory affairs specialists make in New Jersey?
Regulatory affairs specialists in New Jersey earn a median of about $100,000 a year, based on May 2025 Bureau of Labor Statistics wage data, ranging from around $58,860 for the lowest 10% to over $158,540 for the top 10%. Pay rises with experience, specialty, and employer.
Which companies hire regulatory affairs specialists in New Jersey?
Employers hiring regulatory affairs specialists in New Jersey right now include Merck, Insmed Incorporated, and BD, based on current listings on Migrate Mate as of September 2026. New Jersey's dense concentration of global pharmaceutical headquarters and contract research organizations means regulatory openings appear at both large established companies and mid-size specialty drug firms throughout the state.
Which New Jersey cities have the most regulatory affairs specialist jobs?
The cities with the most regulatory affairs specialist openings in New Jersey are Morristown, New Jersey, and Rahway. The distribution reflects the Raritan Valley and Princeton corridor's status as a global pharmaceutical hub, where large company campuses anchor demand, while suburban office parks in Morris and Somerset counties draw contract organizations and smaller biotech firms that also carry active regulatory headcount.
Are there remote regulatory affairs specialist jobs in New Jersey?
Yes, and more than most fields, because a significant share of regulatory affairs work involves document preparation, dossier review, and agency correspondence that does not require on-site access. About 71% of regulatory affairs specialist openings tied to New Jersey are remote or hybrid as of September 2026, reflecting the desk-heavy nature of submissions and labeling roles. Positions involving active lab oversight, manufacturing site support, or in-person FDA meetings tend to require a physical presence.
How can I get hired as a regulatory affairs specialist in New Jersey with little or no experience?
The most realistic entry path is a lateral move from a quality assurance, clinical data, or laboratory role at a New Jersey pharmaceutical or contract research organization, where regulatory exposure is built on the job. Large employers like Merck and Johnson & Johnson run rotational programs and associate scientist tracks that include regulatory assignments for candidates with relevant science degrees. Completing a regulatory affairs certificate program through a New Jersey university extension, or earning the RAC credential early, distinguishes candidates competing for associate-level openings at smaller specialty pharma companies in the Princeton and Parsippany areas.
Where can I find and apply to regulatory affairs specialist jobs in New Jersey?
You can find and apply to regulatory affairs specialist jobs in New Jersey on Migrate Mate, which lists current openings across the state's pharmaceutical, medical device, and biotechnology employers. Search the listings below to see roles that match your background, and apply directly to the ones that fit.
See All 56 Regulatory Affairs Specialist Jobs in New Jersey
Find roles in New Jersey that match your experience and apply in just a few clicks.
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