Senior Manager, Regulatory Affairs, Advertising & Promotion
Regeneron
August 06, 2026
Remote friendly (Warren, NJ)
United States
Corporate Functions
Work Location: Sleepy Hollow, NY or Warren, NJ (4 days per week on-site)
Responsibilities:
- Manage US and Global regulatory activities tied to advertising and promotion for marketed and pipeline products.
- Advise on development of product messages and related materials across functional areas.
- Provide regulatory guidance to Commercial and Medical Affairs for conference exhibits, disease awareness, and speaker programs.
- Review US/Global product and disease-state materials/communications to ensure compliance with applicable laws, regulations, and guidance.
- Collaborate with Marketing, Medical Affairs, and Legal.
- Coordinate with co-promote partner-company regulatory advertising/promotion professionals.
- Lead/support interactions with FDA Office of Prescription Drug Promotion (OPDP), including advisory submission requests.
- Ensure compliance with promotional material submissions to FDA on Form 2253.
- Monitor evolving regulatory requirements and FDA enforcement impacts; provide regular updates and guidance.
- Drive process improvement for promotional review and standardize portfolio policies.
- Cross-train across products/indications to provide continuous Regulatory A&P support.
- Provide input with Regulatory Therapeutic Area Leads for marketing application summary documents and study reports.
- Contribute to review cycles, labeling development, and negotiations to reflect commercialization objectives/messages.
Qualifications/Skills:
- 3–4+ years in regulatory affairs, preferably advertising and promotion.
- BS in Life Sciences minimum; advanced degree preferred (Masters/PharmD/PhD/MD/DO).
- Strong knowledge of pharmaceutical product development/marketing regulations focused on advertising and promotion.
- Pharmaceutical experience required; biologics experience a plus.
- Preferred: experience with FDA (OPDP/APLB).
- Ability to review promotional materials and provide strategic regulatory advice; excellent written/verbal communication.
- Desirable: support global promotional review; familiarity with clinical trial recruitment materials and labeling regulations.
- Ability to influence cross-functional teams and interact with senior management.
Application Instructions:
- Apply now.
Responsibilities:
- Manage US and Global regulatory activities tied to advertising and promotion for marketed and pipeline products.
- Advise on development of product messages and related materials across functional areas.
- Provide regulatory guidance to Commercial and Medical Affairs for conference exhibits, disease awareness, and speaker programs.
- Review US/Global product and disease-state materials/communications to ensure compliance with applicable laws, regulations, and guidance.
- Collaborate with Marketing, Medical Affairs, and Legal.
- Coordinate with co-promote partner-company regulatory advertising/promotion professionals.
- Lead/support interactions with FDA Office of Prescription Drug Promotion (OPDP), including advisory submission requests.
- Ensure compliance with promotional material submissions to FDA on Form 2253.
- Monitor evolving regulatory requirements and FDA enforcement impacts; provide regular updates and guidance.
- Drive process improvement for promotional review and standardize portfolio policies.
- Cross-train across products/indications to provide continuous Regulatory A&P support.
- Provide input with Regulatory Therapeutic Area Leads for marketing application summary documents and study reports.
- Contribute to review cycles, labeling development, and negotiations to reflect commercialization objectives/messages.
Qualifications/Skills:
- 3–4+ years in regulatory affairs, preferably advertising and promotion.
- BS in Life Sciences minimum; advanced degree preferred (Masters/PharmD/PhD/MD/DO).
- Strong knowledge of pharmaceutical product development/marketing regulations focused on advertising and promotion.
- Pharmaceutical experience required; biologics experience a plus.
- Preferred: experience with FDA (OPDP/APLB).
- Ability to review promotional materials and provide strategic regulatory advice; excellent written/verbal communication.
- Desirable: support global promotional review; familiarity with clinical trial recruitment materials and labeling regulations.
- Ability to influence cross-functional teams and interact with senior management.
Application Instructions:
- Apply now.