Associate Director, US Regulatory Affairs- Promotional & Advertising - Shionogi : Job Details

Serves as internal subject matter expert on promotional and medical review committees for assigned products to ensure compliance with regulatory requirements while meeting corporate strategic promotional objectives. Collaborates with cross-functional teams, including Commercial, Medical, Legal, and other expertise areas for review and approval of promotional materials and materials used in scientific exchange for assigned products. Provides guidance and strategic support on proposed claims for products in development and develops Important Safety Information and Brief Summary documents as needed. Serves as primary liaison with OPDP for assigned products and manages interactions including responses to regulatory inquiries or actions, preparing high quality submissions for advisory comments, and as needed discussions. Educates colleagues on the regulatory environment and provides a risk assessment for proposed communication tactics and strategies. Continually develops, revises, and asses...Regulatory Affairs, Director, Advertising, Regulatory, Associate, Skills, Business Services