Assoc. Director, Regulatory Affairs Advertising and Promotion

Serve as the internal subject matter expert on FDA Advertising & Promotion matters, providing regulatory advice and reconciling comments on draft promotional materials to maintain compliance. Review and approve all promotional, medical, and social media postings within the PromoMats system, ensuring changes in prescribing information are reflected in current communications. Liaise with the FDA Office of Prescription Drug Promotion and Advertising and Promotion Labeling Branch as the single point of contact, managing interactions, responding to inquiries, and preparing complete submissions. Lead the Medical, Legal, Regulatory review process, develop streamlined workflows for promotional activities, and provide training on FDA requirements and company policies.