Director, Regulatory Affairs (Advertising and Promotions)

Role: Director of Regulatory Affairs (Advertising & Promotion) overseeing FDA-regulated promotional review for biopharma products, including social media and medical communications. Responsibilities: review and approve promotional materials and social media posts, liaise with FDA OPDP/APLB, manage regulatory interactions, ensure compliance with FDA and PhRMA guidelines, contribute to labeling strategies, and develop review processes. Requirements: minimum BS in science (advanced degree preferred), 10+ years in pharma/biotech, at least 5 years in promotional review, strong knowledge of FDA promotional regulations, experience supporting CNS or psychedelics is a plus, proficiency with Veeva PromoMats preferred. HighValue: focus on CNS/psychedelics, regulatory review, FDA interactions, promotional compliance, supporting marketed and developmental psychiatric products. WorkSetup: not specified; likely office-based with potential cross-functional collaboration.