Director, Regulatory Ad Promo

Role: Director, Regulatory Affairs, Advertising and Promotion, overseeing regulatory compliance and strategic communication of Alkermes products. Responsibilities: review and approve promotional materials for consistency with labeling and FDA regulations; participate in multi-disciplinary teams and serve as chair for Copy Clearance Committees; maintain expertise in FDA laws and guidances; advise internal teams; ensure timely FDA submissions; develop procedures to streamline review processes; and train staff on regulatory requirements. Requirements: Bachelor's in health/science or higher; 10+ years of regulatory advertising and promotion review experience; deep knowledge of FDA regulations; strong communication, negotiation, and compliance skills. HighValue: extensive FDA regulatory expertise, promotional review leadership, strategic compliance advising, cross-functional collaboration, and ability to manage complex communication processes. WorkSetup: remote with up to 20% travel.