Manager, Regulatory Advertising & Promotion

Role: Manager, Regulatory Advertising & Promotion, responsible for preparing and managing FDA OPDP submissions of prescription drug promotional materials, ensuring compliance with FDA regulations, and supporting promotional review processes. Responsibilities include coordinating electronic submissions (Form FDA 2253), maintaining accurate records, troubleshooting submission issues, and partnering with Regulatory Operations. Additional duties involve monitoring FDA enforcement trends, developing training resources, and supporting inspection readiness related to promotional activities. Requirements: Bachelor's degree in life sciences, pharmacy, or regulatory affairs; 5+ years in pharmaceutical or biotech industry, with specific experience in FDA-regulated promotional materials and OPDP submissions. Preferred skills include familiarity with electronic submission platforms like Veeva PromoMats, eCTD, and experience supporting marketed prescription drugs in the U.S. High-value biopharma specifics: focus on prescription drug advertising, regulatory compliance, FDA submission processes, and cross-functional collaboration with Commercial, Medical, and Regulatory teams. The role offers flexible work arrangements (20-40% remote), with no specific travel requirements stated.