Director, Regulatory Affairs (Advertising and Promotion)

The Director of Advertising and Promotion, Prescription Drug Products manages and/or participates in the review, approval and monitoring of prescription drug advertising and promotional labeling pieces. 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. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs. • Knowledge of regulations related to prescription drug promotion • Previous course and/or conference training in advertising and promotion • Working knowledge of Rx NDA and labeling development and approval process • Detail-oriented with the ability to promptly assess documents for accuracy as well as consistency • Strong interpersonal skills with the ability to influence, without authority, others in a positive and effective manner