Director, US Regulatory Advertising & Promotion (Remote)

Role: Director of Commercial Regulatory Affairs, overseeing FDA promotional review and compliance for assigned brand(s). Objectives: ensure promotional materials meet FDA, PhRMA DTC, and company standards; maintain effective FDA interactions; support compliant marketing strategies. Responsibilities: serve as regulatory expert on FDA advertising issues; lead PRC and MRC review processes; develop SOPs for workflow efficiency; liaise with FDA (OPDP/APLB) on submissions and inquiries; collaborate cross-functionally to align regulatory guidance with commercial goals; lead content lifecycle management and training. Requirements: minimum 8 years in pharma with 6+ years in regulatory affairs; deep expertise in FDA advertising regulations, drug labeling, and promotional review; proven experience authoring submissions and managing FDA interactions; strong communication, negotiation, and cross-functional influence skills; Bachelor's in a scientific discipline, fluency in English; experience in rare diseases, neuroscience, or oncology preferred. HighValue: US-focused promotional regulatory oversight, FDA interactions, cross-functional collaboration with Marketing, Medical, Legal, and Regulatory teams. WorkSetup: unspecified, likely office-based or hybrid given FDA engagement.