Senior Manager, Regulatory Affairs, Advertising & Promotion

Overview 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 understanding of advertising and promotion regulations to develop 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 with minimal guidance from the Regulatory Affairs, Advertising and Promotion Director. The Senior Manager Regulatory Affairs, Advertising and Promotion will oversee therapeutic areas and ensure messages are translated into advertising and promotion initiatives that meet the commercial team’s objectives while maintaining compliance and corporate integrity. When & Where Work Location: Sleepy Hollow, NY or Warren, NJ Hybrid: 4 days per week on site Discover Your Role Management of US and Global 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. 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 Requires A minimum of 3 to 4 years within regulatory affairs, preferably within advertising and promotion At minimum, a Bachelor’s degree in Life Sciences. Advanced degree (Masters, Pharm D, Ph.D., MD or DO) preferred. Regulatory experience can offset education requirements. Advanced knowledge of regulations, guidelines, and precedents related to pharmaceutical product development and marketing, focusing on advertising and promotion Experience with pharmaceutical products; biologics experience is a plus Experience working directly/indirectly with the FDA, specifically OPDP/APLB is preferred Ability to review promotional materials and interact with FDA OPDP/APLB while providing strategic regulatory advice Ability to support global promotional review, understanding of clinical trial recruitment materials, and familiarity with labeling regulations Ability to influence cross-functional teams and interact with senior management Salary Range (annually): $150,500.00 - $245,500.00 #J-18808-Ljbffr