Associate Director, Global Regulatory Affairs Advertising and Promotion - Sanofi : Job Details

Represents Global Regulatory Affairs (US RA Ad. Promo) as a member of cross-functional brand and portfolio team review committees (RC), providing regulatory input into the review and approval of US advertising, promotion, disease-state, market access, and press materials. Submits materials on form FDA 2253 when applicable. Provides US RA Ad. Promo strategic guidance and subject matter expertise for responsible investigational and marketed products, to meet both short- and long-term business objectives while mitigating risk. Consults with senior management and provides input to the Global organization as needed. Contributes US RA Ad. Promo input to the development of optimal FDA product labeling on original and supplemental New Drug Applications and/or Biologics License Applications. Primary Liaison with OPDP/ APLB and effectively manages relationships with FDA contacts. Establishes and maintains strong collaborative relationships with Regulatory and other R&D colleagues, as well as oth...Regulatory Affairs, Director, Advertising, Associate, Regulatory, Global, Business Services