Associate Director, Regulatory Affairs Advertising and Promotion

Responsibilities Serve as the internal subject matter expert on FDA Advertising & Promotion matters for assigned products Review and approve promotional, medical, and social media materials in the PromoMats system Liaise with OPDP/APLB (FDA) as the single point of contact for advertising and promotional matters Manage FDA regulatory inquiries and prepare high-quality submissions for advisory comments Ensure timely and accurate FDA 2253 submissions of US promotional materials Ensure prescribing information updates are reflected in all current promotional and advertising materials Develop processes and standards to facilitate streamlined workflows for the review process Provide regulatory training on FDA requirements, PhRMA DTC Guidelines, and company policies Requirements Minimum BS in a scientific discipline (advanced science degree preferred) Minimum 8 years of pharmaceutical industry experience At least 5 years of experience in regulatory affairs Expert knowledge of advertising promotion regulations and FDA Guidance documents Solid experience with promotional and medical review and working with FDA (OPDP, APLB) Preferred Qualifications Experience in CNS (Central Nervous System) therapeutic areas Experience with Veeva PromoMats Benefits 100% paid health benefits including Medical, Dental, and Vision for employees and dependents 401(k) program with company match Flexible time off Generous parental leave About the Company Definium Therapeutics is a late-stage clinical biopharmaceutical company focused on applying scientific rigor to psychedelics to develop accessible treatments for psychiatric and neurological disorders. #J-18808-Ljbffr