Director, Regulatory Affairs Advertising and Promotion

Role: Director of Regulatory Advertising & Promotion overseeing U.S. promotional activities for cell and gene therapy products. Responsibilities: lead regulatory review of promotional and non-promotional materials, ensure compliance with FDA regulations, serve as key partner to Medical Affairs, Marketing, and Legal, and develop submission strategies for health authority review. Lead governance efforts to maintain SOPs, workflows, and training related to advertising and promotion. Requirements: advanced degree (PharmD, PhD, MD, JD), 10+ years in biotech/pharma regulatory roles with experience in promotional compliance, FDA interactions, and MLR review. Preferred: experience in cell/gene therapy or rare diseases. HighValue: focus on highly regulated cell and gene therapy products, FDA compliance, MLR review, cross-functional leadership, and experience in biotech or pharma, based in Massachusetts with a hybrid work setup.