Sr. manager/associate director, regulatory affairs advertising & promotion - (Bothell, WA)

Sr. Manager/Associate Director, Regulatory Affairs Advertising & Promotion Regulatory Affairs Bothell, Washington Description Responsibilities: Supporting or carrying out interactions with the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) for assigned product(s) Contributing to/providing strategic regulatory advice on promotional materials and activities, including the development of launch materials/new claims, in accordance with business goals and objectives Managing timelines and resources to achieve stated goals Reviewing and approving consumer and professional promotional materials for marketed products, corporate communications, educational and training materials, via the promotional review committee (PRC) process Reviewing and approving of non-promotional scientific and medical communications for development stage products, via the medical/legal/regulatory affairs (MLR) review committee process Contributing to/providing regulatory advisory submission strategies