Associate Director, Regulatory Advertising and Promotion

Role: Associate Director, Regulatory Affairs, Advertising and Promotion, supporting FDA-regulated communications for Alkermes products in neurological and psychiatric indications. Responsibilities include reviewing promotional materials for compliance, leading multi-disciplinary teams such as Copy Clearance and Labeling Committees, maintaining knowledge of FDA laws and guidances, providing regulatory training, and managing FDA submissions like Form FDA-2253. The role involves strategic interactions with internal departments (Marketing, Legal, Medical) and external health authorities. Requirements: Bachelor's or advanced degree in health/science, minimum 7 years of regulatory review experience in pharma/biotech, strong knowledge of FDA regulations, excellent communication and negotiation skills, and ability to interpret clinical data. Preferred: up to 20% travel, interpersonal skills, and clarity in complex issue communication. HighValue: focus on pharma advertising/promotional compliance, FDA interaction, cross-functional collaboration, and experience with neurological/psychiatric therapeutics. WorkSetup: hybrid (60% office, 40% remote) in Waltham, MA; onsite at least 3 days/week.