Manager, Regulatory Affairs, Advertising & Promotion
Regeneron
August 10, 2026
Remote friendly (Warren, NJ)
United States
Corporate Functions
Responsibilities:
- Manage US regulatory activities for advertising and promotion of marketed products; oversee 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 and Medical Affairs for conference exhibit activities, disease awareness, and speaker programs.
- Review US and Global (if applicable) product and disease-state materials/communications to support corporate goals and ensure compliance with applicable laws, regulations, and guidance.
- Collaborate cross-functionally with Marketing, Medical Affairs, and Legal.
- Manage relationships and communication with regulatory advertising/promotion professionals at co-promote partner companies.
- Lead/support interactions with FDA Office of Prescription Drug Promotion (OPDP); maintain effective communication with OPDP reviewers, including advisory submissions.
- Ensure compliance with promotional material submissions to FDA on Form 2253.
- Monitor external regulatory environment and advise on evolving requirements.
- Track FDA promotional enforcement activities; provide stakeholder updates and guidance on policy impact.
- Identify process improvements to standardize promotional review policies portfolio-wide.
- Cross-train across products/indications to ensure continuous Regulatory A&P support.
- 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 promotion/advertising messages.
Qualifications:
- Minimum 2 years relevant experience, preferably in Regulatory Advertising and Promotion.
- BS in Life Sciences minimum; advanced degree (MS, PharmD, PhD) preferred.
- Knowledge of advertising/promotion regulations, guidelines, and precedents in pharmaceutical product development and marketing.
- Pharmaceutical product experience required; biologics experience a plus.
- Experience working with FDA, specifically OPDP/APLB, preferred.
- Ability to review promotional materials and support launch products/campaigns; strong written/verbal communication.
- Global promotional review support experience; familiarity with clinical trial recruitment materials and labeling regulations desirable.
Application instructions:
- Apply now.
- Manage US regulatory activities for advertising and promotion of marketed products; oversee 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 and Medical Affairs for conference exhibit activities, disease awareness, and speaker programs.
- Review US and Global (if applicable) product and disease-state materials/communications to support corporate goals and ensure compliance with applicable laws, regulations, and guidance.
- Collaborate cross-functionally with Marketing, Medical Affairs, and Legal.
- Manage relationships and communication with regulatory advertising/promotion professionals at co-promote partner companies.
- Lead/support interactions with FDA Office of Prescription Drug Promotion (OPDP); maintain effective communication with OPDP reviewers, including advisory submissions.
- Ensure compliance with promotional material submissions to FDA on Form 2253.
- Monitor external regulatory environment and advise on evolving requirements.
- Track FDA promotional enforcement activities; provide stakeholder updates and guidance on policy impact.
- Identify process improvements to standardize promotional review policies portfolio-wide.
- Cross-train across products/indications to ensure continuous Regulatory A&P support.
- 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 promotion/advertising messages.
Qualifications:
- Minimum 2 years relevant experience, preferably in Regulatory Advertising and Promotion.
- BS in Life Sciences minimum; advanced degree (MS, PharmD, PhD) preferred.
- Knowledge of advertising/promotion regulations, guidelines, and precedents in pharmaceutical product development and marketing.
- Pharmaceutical product experience required; biologics experience a plus.
- Experience working with FDA, specifically OPDP/APLB, preferred.
- Ability to review promotional materials and support launch products/campaigns; strong written/verbal communication.
- Global promotional review support experience; familiarity with clinical trial recruitment materials and labeling regulations desirable.
Application instructions:
- Apply now.