Associate Director, Regulatory Affairs Advertising and Promotion

Role: Associate Director, Regulatory Affairs Advertising and Promotion, overseeing regulatory compliance for commercial activities related to pharmaceutical products. Responsibilities: provide regulatory guidance for promotional materials, manage and author submissions to the FDA’s Office of Prescription Drug Promotion (OPDP), develop strategies and timelines for advertising campaigns, and contribute to process improvements within MLR. Requirements: bachelor’s or higher in a scientific discipline; 8+ years in Regulatory Affairs with at least 6 years focused on advertising and promotional review for prescription drugs or biologics. Skills include in-depth knowledge of FDA OPDP regulations, strong communication, critical review of technical documents, and stakeholder engagement. HighValue: experience with FDA promotional submissions, regulatory review of pharma advertising, familiarity with global marketing laws, and ability to work in a fast-paced, high-growth environment. WorkSetup: hybrid; some travel; high-growth, fast-paced setting.