Manager, Regulatory Affairs, Advertising & Promotion
Regeneron
August 06, 2026
Remote friendly (Sleepy Hollow, NY)
United States
Corporate Functions
Responsibilities:
- Manage US regulatory activities for advertising and promotion of marketed products.
- Advise on development of product messages and materials across functional areas.
- Provide timely regulatory guidance 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 ensure compliance with applicable laws, regulations, and guidance.
- Collaborate with Marketing, Medical Affairs, and Legal.
- Manage relationships and communications with regulatory advertising and promotion professionals at co-promote partner companies.
- Lead/assist FDA interactions with the Office of Prescription Drug Promotion (OPDP), including advisory submissions.
- Ensure compliance with FDA promotional material submissions on Form 2253.
- Monitor evolving regulatory requirements for product and disease-state communications.
- Track and respond to FDA promotional enforcement activities; provide stakeholder updates and guidance.
- Identify process improvements for promotional review to standardize policies portfolio-wide.
- Cross-train across products/indications to support continuous Regulatory A&P coverage.
- Partner with Regulatory Therapeutic Area Leads to review marketing application summary documents and study reports.
- Provide input during review cycles and labeling development/negotiation to reflect commercialization objectives and messages.
Qualifications:
- 2+ years relevant experience, preferably in Regulatory Advertising & Promotion.
- BS in Life Sciences (Masters/PharmD/PhD preferred).
- Knowledge of pharmaceutical development and marketing regulations/guidelines focused on advertising and promotion.
- Pharmaceutical experience required; biologics experience preferred.
- FDA experience preferred (OPDP/APLB).
- Strong written/verbal communication for strategic regulatory advice.
- Global promotional review support experience and familiarity with clinical trial recruitment materials and labeling regulations desirable.
Application:
- Apply now.
- Manage US regulatory activities for advertising and promotion of marketed products.
- Advise on development of product messages and materials across functional areas.
- Provide timely regulatory guidance 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 ensure compliance with applicable laws, regulations, and guidance.
- Collaborate with Marketing, Medical Affairs, and Legal.
- Manage relationships and communications with regulatory advertising and promotion professionals at co-promote partner companies.
- Lead/assist FDA interactions with the Office of Prescription Drug Promotion (OPDP), including advisory submissions.
- Ensure compliance with FDA promotional material submissions on Form 2253.
- Monitor evolving regulatory requirements for product and disease-state communications.
- Track and respond to FDA promotional enforcement activities; provide stakeholder updates and guidance.
- Identify process improvements for promotional review to standardize policies portfolio-wide.
- Cross-train across products/indications to support continuous Regulatory A&P coverage.
- Partner with Regulatory Therapeutic Area Leads to review marketing application summary documents and study reports.
- Provide input during review cycles and labeling development/negotiation to reflect commercialization objectives and messages.
Qualifications:
- 2+ years relevant experience, preferably in Regulatory Advertising & Promotion.
- BS in Life Sciences (Masters/PharmD/PhD preferred).
- Knowledge of pharmaceutical development and marketing regulations/guidelines focused on advertising and promotion.
- Pharmaceutical experience required; biologics experience preferred.
- FDA experience preferred (OPDP/APLB).
- Strong written/verbal communication for strategic regulatory advice.
- Global promotional review support experience and familiarity with clinical trial recruitment materials and labeling regulations desirable.
Application:
- Apply now.