Senior Manager, Regulatory Affairs, Advertising & Promotion
Regeneron
June 24, 2026
Remote friendly (Warren, NJ)
United States
Corporate Functions
Responsibilities:
- Manage US and global regulatory activities for advertising/promotion of marketed products and commercial development of pipeline products; oversee from a regulatory advertising & promotion perspective with minimal guidance.
- Advise on development of product messages/materials across functional areas.
- Provide regulatory advice to Commercial and Medical Affairs for conference exhibit activities, disease awareness, and speaker programs.
- Review US/global product and disease state materials/communications to support corporate goals and ensure compliance with applicable laws, regulations, and guidance.
- Collaborate with Marketing, Medical Affairs, and Legal.
- Manage communications/relationships with co-promote partner companies’ regulatory advertising/promotion professionals.
- Lead interactions with FDA OPDP (including advisory submissions).
- Ensure compliance with promotional material submissions to FDA on Form 2253.
- Monitor evolving regulatory requirements; update stakeholders on FDA promotional enforcement and related policy impacts.
- Improve promotional review processes and standardize portfolio-wide policies.
- Cross-train across products/indications; collaborate with Regulatory Therapeutic Area Leads on marketing application summary documents and study reports.
- Provide input during review cycles and labeling development/negotiation to reflect commercialization objectives and messages.
Qualifications:
- 3–4+ years in regulatory affairs (preferably advertising/promotion).
- Bachelor’s (Life Sciences) minimum; advanced degree (MS/PharmD/PhD/MD/DO) preferred.
- Advanced knowledge of pharmaceutical advertising/promotion regulations, guidelines, and precedents.
- Pharmaceutical product experience required (biologics a plus).
- FDA experience (OPDP/APLB preferred).
- Ability to review promotional materials and advise strategically with strong written/verbal communication.
- Global promotional review support; clinical trial recruitment materials and labeling regulation familiarity desirable.
- Ability to influence cross-functional teams and interact with senior management.
Application instructions:
- Apply now.
- Manage US and global regulatory activities for advertising/promotion of marketed products and commercial development of pipeline products; oversee from a regulatory advertising & promotion perspective with minimal guidance.
- Advise on development of product messages/materials across functional areas.
- Provide regulatory advice to Commercial and Medical Affairs for conference exhibit activities, disease awareness, and speaker programs.
- Review US/global product and disease state materials/communications to support corporate goals and ensure compliance with applicable laws, regulations, and guidance.
- Collaborate with Marketing, Medical Affairs, and Legal.
- Manage communications/relationships with co-promote partner companies’ regulatory advertising/promotion professionals.
- Lead interactions with FDA OPDP (including advisory submissions).
- Ensure compliance with promotional material submissions to FDA on Form 2253.
- Monitor evolving regulatory requirements; update stakeholders on FDA promotional enforcement and related policy impacts.
- Improve promotional review processes and standardize portfolio-wide policies.
- Cross-train across products/indications; collaborate with Regulatory Therapeutic Area Leads on marketing application summary documents and study reports.
- Provide input during review cycles and labeling development/negotiation to reflect commercialization objectives and messages.
Qualifications:
- 3–4+ years in regulatory affairs (preferably advertising/promotion).
- Bachelor’s (Life Sciences) minimum; advanced degree (MS/PharmD/PhD/MD/DO) preferred.
- Advanced knowledge of pharmaceutical advertising/promotion regulations, guidelines, and precedents.
- Pharmaceutical product experience required (biologics a plus).
- FDA experience (OPDP/APLB preferred).
- Ability to review promotional materials and advise strategically with strong written/verbal communication.
- Global promotional review support; clinical trial recruitment materials and labeling regulation familiarity desirable.
- Ability to influence cross-functional teams and interact with senior management.
Application instructions:
- Apply now.