Manager, Regulatory Affairs, Advertising & Promotion
Regeneron
June 28, 2026
Remote friendly (Warren, NJ)
United States
Marketing
Manager, Regulatory Affairs Advertising and Promotion
Work Location/Model:
- Sleepy Hollow, NY or Warren, NJ; Hybrid (4 days per week on site)
Discover Your Role:
- Manage US regulatory activities for advertising and promotion of marketed products.
- Advise on development of product messages and materials across functional areas.
- Provide 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 for compliance with applicable laws/regulations/guidance.
- Collaborate cross-functionally with Marketing, Medical Affairs, and Legal.
- Manage relationships/communication with co-promote partner company regulatory advertising and promotion professionals.
- Lead/assist FDA Office of Prescription Drug Promotion (OPDP) interactions, including advisory submissions.
- Ensure compliance with promotional material submissions to FDA on Form 2253.
- Monitor evolving regulatory requirements and FDA promotional enforcement; provide stakeholder updates and policy guidance.
- Identify process improvements for promotional review and support portfolio-wide standardization.
- Cross-train across products/indications to maintain Regulatory A&P support.
- Review marketing application summary documents and study reports with Regulatory Therapeutic Area Leads.
- 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 (Masters/PharmD/PhD preferred).
- Knowledge of pharmaceutical product development and marketing regulations/guidelines, with focus on advertising and promotion.
- Pharmaceutical experience required (biologics a plus).
- FDA experience preferred, specifically OPDP/APLB.
- Ability to review promotional materials, interact with FDA OPDP/APLB, and support launch products/campaigns with strong written/verbal strategic regulatory communication.
- Global promotional review support experience; clinical trial recruitment materials knowledge and labeling familiarity desirable.
Work Location/Model:
- Sleepy Hollow, NY or Warren, NJ; Hybrid (4 days per week on site)
Discover Your Role:
- Manage US regulatory activities for advertising and promotion of marketed products.
- Advise on development of product messages and materials across functional areas.
- Provide 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 for compliance with applicable laws/regulations/guidance.
- Collaborate cross-functionally with Marketing, Medical Affairs, and Legal.
- Manage relationships/communication with co-promote partner company regulatory advertising and promotion professionals.
- Lead/assist FDA Office of Prescription Drug Promotion (OPDP) interactions, including advisory submissions.
- Ensure compliance with promotional material submissions to FDA on Form 2253.
- Monitor evolving regulatory requirements and FDA promotional enforcement; provide stakeholder updates and policy guidance.
- Identify process improvements for promotional review and support portfolio-wide standardization.
- Cross-train across products/indications to maintain Regulatory A&P support.
- Review marketing application summary documents and study reports with Regulatory Therapeutic Area Leads.
- 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 (Masters/PharmD/PhD preferred).
- Knowledge of pharmaceutical product development and marketing regulations/guidelines, with focus on advertising and promotion.
- Pharmaceutical experience required (biologics a plus).
- FDA experience preferred, specifically OPDP/APLB.
- Ability to review promotional materials, interact with FDA OPDP/APLB, and support launch products/campaigns with strong written/verbal strategic regulatory communication.
- Global promotional review support experience; clinical trial recruitment materials knowledge and labeling familiarity desirable.