Manager, Regulatory Affairs, Advertising & Promotion
Regeneron
June 24, 2026
Remote friendly (Sleepy Hollow, NY)
United States
Corporate Functions
Discover Your Role
- Management of US regulatory activities associated with advertising and promotion of marketed products; manage commercial activities from a regulatory advertising/promotion perspective.
- Contribute to development of product messages and materials across multiple functional areas.
- Provide timely regulatory advice to Commercial teams and Medical Affairs for conference exhibits, disease awareness, and speaker programs.
- Review US and Global (if applicable) product and disease state materials/communications to support corporate goals and comply with laws, regulations, and guidance.
- Collaborate cross-functionally with Marketing, Medical Affairs, and Legal.
- Establish relationships and manage communication with regulatory advertising/promotion professionals at co-promote partner companies.
- Lead interactions with the FDA Office of Prescription Drug Promotion (OPDP), including advisory submissions.
- Ensure compliance with promotional material submissions to FDA on Form 2253.
- Monitor evolving regulatory requirements; maintain vigilance regarding FDA promotional enforcement activities and advise stakeholders.
- Identify process improvements for promotional review activities and support portfolio-wide standardization.
- Cross-train across products/indications to provide continuous Regulatory A&P support.
- Collaborate with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports.
- Provide input during review cycles and labeling development/negotiation to reflect commercialization objectives and messages.
This Role Requires
- 2+ years relevant experience, preferably in Regulatory Advertising and Promotion.
- BS in Life Sciences (advanced degree preferred: MS, PharmD, PhD).
- Knowledge of advertising/promotion regulations/guidelines for pharma product development and marketing.
- Pharmaceutical experience required; biologics experience a plus.
- Experience with FDA (OPDP/APLB preferred).
- Ability to review promotional materials, interact with FDA OPDP/APLB, and provide strong written/verbal strategic regulatory advice.
- Global promotional review support experience; familiarity with clinical trial recruitment materials and labeling regulations desirable.
- Management of US regulatory activities associated with advertising and promotion of marketed products; manage commercial activities from a regulatory advertising/promotion perspective.
- Contribute to development of product messages and materials across multiple functional areas.
- Provide timely regulatory advice to Commercial teams and Medical Affairs for conference exhibits, disease awareness, and speaker programs.
- Review US and Global (if applicable) product and disease state materials/communications to support corporate goals and comply with laws, regulations, and guidance.
- Collaborate cross-functionally with Marketing, Medical Affairs, and Legal.
- Establish relationships and manage communication with regulatory advertising/promotion professionals at co-promote partner companies.
- Lead interactions with the FDA Office of Prescription Drug Promotion (OPDP), including advisory submissions.
- Ensure compliance with promotional material submissions to FDA on Form 2253.
- Monitor evolving regulatory requirements; maintain vigilance regarding FDA promotional enforcement activities and advise stakeholders.
- Identify process improvements for promotional review activities and support portfolio-wide standardization.
- Cross-train across products/indications to provide continuous Regulatory A&P support.
- Collaborate with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports.
- Provide input during review cycles and labeling development/negotiation to reflect commercialization objectives and messages.
This Role Requires
- 2+ years relevant experience, preferably in Regulatory Advertising and Promotion.
- BS in Life Sciences (advanced degree preferred: MS, PharmD, PhD).
- Knowledge of advertising/promotion regulations/guidelines for pharma product development and marketing.
- Pharmaceutical experience required; biologics experience a plus.
- Experience with FDA (OPDP/APLB preferred).
- Ability to review promotional materials, interact with FDA OPDP/APLB, and provide strong written/verbal strategic regulatory advice.
- Global promotional review support experience; familiarity with clinical trial recruitment materials and labeling regulations desirable.