Director, Regulatory Affairs (Advertising and Promotion)

Someone who is imaginative and proactive, with a keen eye for what is possible. Updates the Regulatory Affairs advertising and promotion staff, review committees and appropriate other Company staff regarding changes in the current regulatory environment at FDA’s Office of Prescription Drug promotion (OPDP), Advertising and Promotional Labeling Branch (APLB), and other regulatory considerations that may impact business. • Works closely with the Regulatory Affairs prescription drug labeling group regarding package insert changes to assess and determine the impact of proposed labeling changes on product promotion. Other job responsibilities as needed. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs.