RoleDirector of Regulatory Affairs (Advertising & Promotion) overseeing FDA-regulated promotional review for biopharma products, including social media and medical communications.
Responsibilitiesreview 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.
Requirementsminimum 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
High Valuefocus on CNS/psychedelics
regulatory review
FDA interactions
promotional compliance
supporting marketed and developmental psychiatric products
Work Setupnot specified; likely office-based with potential cross-functional collaboration.
