Associate Director, Regulatory Affairs, Advertising, Promotion & Labeling

The Associate Director, Advertising, Promotion and Labeling will execute regulatory oversight for advertising, promotion, medical communications, and product labeling from pre-launch planning through lifecycle management. This is a critical role responsible for developing and executing regulatory strategy for all product communications and core labeling. This role will ensure that commercial and non-promotional materials, as well as core and local product labeling, are compliant with US FDA, EMA, and other relevant global regulations. The role requires expert-level interpretation of complex regulatory requirements and a proven ability to influence cross-functional teams to achieve both compliance and business goals. Title: Associate Director, Advertising, Promotion and Labeling Location: Remote (West Coast hours preferred) Reports to: SVP, Chief Regulatory Officer Responsibilities Serve as regulatory lead for promotional and medical review committees, providing practical, risk-based guidance on claims, supporting evidence, fair balance, and multichannel communications. Provide strategic, proactive regulatory guidance on the development of all promotional, advertising, and educational materials across all channels (print, digital, social media, speaker programs, formulary communications) to ensure fair balance and consistency with the US Prescribing Information (USPI). Lead interactions with the US FDA Office of Prescription Drug Promotion (OPDP) and, where applicable, the Adv