Director, US Regulatory Affairs, Advertising & Promotion

Role: Lead regulatory review and compliance for U.S. advertising and promotional materials, ensuring FDA regulatory adherence and supporting product claims. Responsibilities: oversee approval processes, serve as regulatory expert for promotional activities, influence cross-functional decisions, mentor junior staff, and manage FDA interactions and submissions (e.g., Form 2253, advisory comments). Lead continuous process improvements, monitor FDA guidance, and train marketing, sales, and medical teams on compliance. Qualifications: Bachelor’s degree required; PharmD, PhD, or JD preferred. Minimum 10 years in pharma/biotech regulatory affairs, with at least 7 years focused on US advertising/promotion and successful product launches. Skills: expert knowledge of FDA regulations for biologics and promotion, proficiency with Veeva Vault PromoMats, strong clinical data interpretation, and excellent communication. HighValue: biologics, cardiovascular indications, US market, regulatory advertising/promotion, FDA interactions, drug/biologic product launches. WorkSetup: not specified.