Senior Manager, Regulatory Affairs, Advertising & Promotion

Senior Manager, Regulatory Affairs, Advertising & Promotion

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 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).

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

When & where

Work Location:

Sleepy Hollow, NY or Warren, NJ 4 days per week on site

Discover your role –

• Regulatory activities — 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.
• Product messaging — Creatively advise on the development of product messages and materials across multiple functional areas.
• Regulatory guidance — 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.
• Material review — 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.
• Cross-functional collaboration — Collaborate cross-functionally with key stakeholders in areas such as Marketing, Medical Affairs, and Legal.
• Partner communication — Responsible for establishing working relationships and managing communication with regulatory advertising and promotion professionals at co-promote partner companies.
• FDA OPDP interactions — Help lead and assist in all interactions with the FDA Office of Prescription Drug Promotion (OPDP) for assigned company products, responsible for helping to maintain working relationship and effective communication with FDA OPDP reviewers with respect to advertising and promotion matters, including requests for advisory submissions.
• Form 2253 compliance — Responsible for compliance with promotional material submissions to FDA on Form 2253.
• Regulatory monitoring — Monitor the external environment to advise product teams on evolving regulatory requirements related to product and disease state communications.
• Enforcement vigilance — Maintain vigilance with respect to FDA promotional enforcement activities; provide stakeholders with updates on a regular basis; provide guidance to stakeholders with respect to impact of enforcement activities on the company policies.
• Process improvement — Provide input to direct management with respect to process improvement for promotional review activities and establishment of portfolio-wide standardization of policies.
• Cross-training — Ability to cross-train across…