Associate Manager, Regulatory Advertising & Promotion
Regeneron
August 13, 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 regulatory guidance to Commercial and Medical Affairs for conference exhibits, disease awareness, and speaker programs.
- Review US and (if applicable) global product and disease-state materials/communications to support corporate goals and comply with laws/regulations/guidance.
- Collaborate cross-functionally with Marketing, Medical Affairs, and Legal.
- Manage communication with co-promote partner regulatory A&P professionals.
- Liaise with FDA OPDP on advertising/promotion matters, including advisory submissions.
- Ensure compliance with promotional submissions to FDA on Form 2253.
- Monitor evolving regulatory requirements; update stakeholders on FDA promotional enforcement and assess policy impact.
- Support process improvement for promotional review to enable portfolio-wide standardization.
- Provide ongoing Regulatory A&P support across products/indications.
- Partner with Regulatory Therapeutic Area Leads on marketing application summary documents and study reports.
- Support labeling development/negotiation to align commercialization objectives and messages.
Qualifications/Skills:
- 1–2 years in regulatory affairs, preferably advertising/promotion; or Post-Doctoral Fellowship with related Regulatory Affairs/Advertising & Promotion experience.
- Advanced degree (MS, PharmD, PhD) or BS in Life Sciences.
- Strong knowledge of pharmaceutical product development and advertising/promotion regulations/guidelines/precedents.
- Highly preferred: pharmaceutical experience; biologics experience is a plus.
- Desirable: experience working with FDA (OPDP/APLB).
- Ability to review promotional materials, interact with FDA OPDP/APLB, and support launches/campaigns with strong written/verbal communication.
- Desirable: familiarity with global promotional review, clinical trial recruitment materials, and labeling regulations.
- Ability to influence cross-functional teams and interact with senior management.
Application Instructions:
- 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 regulatory guidance to Commercial and Medical Affairs for conference exhibits, disease awareness, and speaker programs.
- Review US and (if applicable) global product and disease-state materials/communications to support corporate goals and comply with laws/regulations/guidance.
- Collaborate cross-functionally with Marketing, Medical Affairs, and Legal.
- Manage communication with co-promote partner regulatory A&P professionals.
- Liaise with FDA OPDP on advertising/promotion matters, including advisory submissions.
- Ensure compliance with promotional submissions to FDA on Form 2253.
- Monitor evolving regulatory requirements; update stakeholders on FDA promotional enforcement and assess policy impact.
- Support process improvement for promotional review to enable portfolio-wide standardization.
- Provide ongoing Regulatory A&P support across products/indications.
- Partner with Regulatory Therapeutic Area Leads on marketing application summary documents and study reports.
- Support labeling development/negotiation to align commercialization objectives and messages.
Qualifications/Skills:
- 1–2 years in regulatory affairs, preferably advertising/promotion; or Post-Doctoral Fellowship with related Regulatory Affairs/Advertising & Promotion experience.
- Advanced degree (MS, PharmD, PhD) or BS in Life Sciences.
- Strong knowledge of pharmaceutical product development and advertising/promotion regulations/guidelines/precedents.
- Highly preferred: pharmaceutical experience; biologics experience is a plus.
- Desirable: experience working with FDA (OPDP/APLB).
- Ability to review promotional materials, interact with FDA OPDP/APLB, and support launches/campaigns with strong written/verbal communication.
- Desirable: familiarity with global promotional review, clinical trial recruitment materials, and labeling regulations.
- Ability to influence cross-functional teams and interact with senior management.
Application Instructions:
- Apply now.