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 understanding of advertising and promotion regulations to develop key product messages presented in Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs). Manages commercial activities from a regulatory advertising and promotion perspective with minimal guidance from the Regulatory Affairs, Advertising & Promotion Director.Advise on the development of product messages and materials across multiple functional areas.Provide timely regulatory advice to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs.Review US and Global product and disease state materials/communications to support corporate goals and comply with laws and guidance.Collaborate cross-functionally with Marketing, Medical Affairs, and Legal.Establish working relationships and manage communication with regulatory advertising and promotion professionals at co-promote partner companies.Lead interactions with the FDA Office of Prescription Drug Promotion (OPDP) and maintain effective communication with FDA OPDP reviewers on advertising and promotion matters, including advisory submissions.Ensure compliance with promotional material submissions to FDA on Form 2253.Monitor the external environment to advise product teams on evolving regulatory requirements for product and disease state communications.Maintain vigilance regarding FDA promotional enforcement activities and provide updates and guidance to stakeholders.Provide input to improve processes for promotional review and standardize portfolio-wide policies.Cross-train across products/indications to ensure ongoing regulatory A&P support.Collaborate with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports.During review cycles, provide input to reflect commercialization objectives and messages in submission documents/reports to health authorities.Contribute to labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising.This Role RequiresA minimum of 3 to 4 years within regulatory affairs, preferably within advertising and promotionAt minimum, a Bachelor’s degree in Life Sciences. Advanced degree (Masters, Pharm D, Ph.D., MD or DO) preferred.