Assoc. Director, Regulatory Affairs Advertising and Promotion

Role: Associate Director, Regulatory Affairs (Advertising & Promotion), overseeing US promotional materials and medical communications for Definium's psychiatric therapeutics, including LSD-based candidate and R-enantiomer of MDMA. Responsibilities: review and approve promotional content, social media posts, and medical materials; liaise with FDA OPDP/APLB; manage interactions and submissions; ensure compliance with FDA, PhRMA, and company policies; develop review processes; provide regulatory training. Requirements: BS in science, advanced degree preferred; 8+ years in pharma with at least 5 in regulatory affairs; strong knowledge of FDA promotion regulations, experience supporting product communications, and working with FDA on advertising approval processes. Preferred: CNS experience, Veeva Promomats expertise. HighValue: focus on CNS pharmacology, promotion regulation, FDA interactions, supporting marketed and investigational psychiatric products. WorkSetup: not specified.