Associate Director, Global Regulatory Advertising and Promotion

Role: Associate Director of Global Regulatory Advertising and Promotion, responsible for ensuring compliance of promotional and non-promotional materials with FDA regulations and industry standards. Responsibilities include reviewing and approving promotional content, guiding promotional strategies during product development, preparing regulatory submissions (e.g., 2253 filings), supporting agency interactions, and developing staff training on promotional regulations. The role requires collaboration with Regulatory Affairs, Legal, Medical, Marketing, and Compliance teams, and may involve interactions with FDA’s APLB. Requirements: Bachelor's degree in Life Sciences, Pharmacy, or Regulatory Affairs; 5+ years in Regulatory Affairs with at least 2 years focused on pharmaceutical advertising/promotional activities; deep knowledge of FDA and global promotional regulations; strong communication, regulatory interpretation, and cross-functional management skills. Preferred: experience with digital/social media promotion, and backgrounds in infectious diseases, oncology, or vaccines. The position is based in a hybrid format, with a salary range of $142,500–$256,500, and may include bonuses or incentives. The candidate should have a comprehensive understanding of GxP, regulatory review processes, and industry enforcement trends, with global regulatory knowledge considered a plus.