Senior Manager, Regulatory Affairs, Advertising & Promotion

Build Our Future Together

At Regeneron, we use science and innovation to develop life‑changing medicines for people with serious diseases. We are seeking a Senior Manager to join our Regulatory Affairs Advertising and Promotion team. This position requires the ability to apply clinical development knowledge in concert with an experienced understanding of advertising and promotion regulations/guidance to the development of key product messages presented in Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs).

The Senior Manager will provide regulatory advertising and promotion expertise to relevant stakeholders, typically carrying out the responsibilities with minimal guidance from the Regulatory Affairs, Advertising & Promotion Director. This role oversees therapeutic area(s) and ensures that messages are translated into advertising and promotion initiatives that meet commercial team objectives while maintaining compliance and corporate integrity.

• Work Location:
  
  Sleepy Hollow, NY or Warren, NJ
• Hybrid: 4 days per week on site

• Management of US and Global (if applicable) regulatory activities associated with advertising and promotion of the company’s marketed products, as well as commercial development of pipeline products. Manages commercial activities from a regulatory advertising and promotion perspective with minimal guidance from the Regulatory Affairs, Advertising & Promotion Director.
• Creatively advise on the development of product messages and materials across multiple functional areas.
• Provide timely regulatory advice and guidance, with minimal guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs.
• Provide review of US and Global (if applicable) product and disease state materials/communications, with minimal guidance from Regulatory Affairs, Advertising & Promotion Director, to support corporate goals and comply with applicable laws, regulations, and guidance.
• Collaborate cross‑functionally with key stakeholders in areas such as Marketing, Medical Affairs, and Legal.
• Responsible for establishing working relationships and managing communication with regulatory advertising and promotion professionals at co‑promote partner companies.
• Help lead and assist in all interactions with the FDA Office of Prescription Drug Promotion (OPDP) for assigned company products, responsible for maintaining effective communication with FDA OPDP reviewers regarding advertising and promotion matters, including request for advisory submissions.
• Responsible for compliance with promotional material submissions to FDA on Form 2253.
• Monitor the external environment to advise product teams on evolving regulatory requirements related to product and disease state communications.
• Maintain vigilance with respect to FDA promotional enforcement activities; provide stakeholders with updates and guidance on the impact of enforcement activities on company policies.
• Provide input to direct management with respect to process improvement for promotional review activities and establishment of portfolio‑wide standardization of policies.
• Ability to cross‑train across products/indications to ensure continuous Regulatory A&P support is provided to stakeholders.
• Collaboration with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports.
• With minimal guidance from management, help provide input during review cycles to reflect commercialization objectives and messages in the submission documents/reports that are submitted to health authorities.
• Provide input to management during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising.

• A minimum of 3 to 4 years within regulatory affairs, preferably within advertising and promotion.
• At minimum a Bachelor’s degree (BS) from an accredited college or university in Life Sciences. Advanced degree (Master’s, Pharm D, Ph.D., MD or DO) preferred in medicine or science.…