Senior Manager, US Medical Ad/Promo Regulatory Review

Role: Senior Manager, US Medical Ad/Promo Regulatory Review, serving as an internal FDA regulatory expert for prescription drugs and biologics, ensuring compliant promotional materials. Responsibilities: interpret complex regulatory issues, mentor staff, lead promotional review meetings, liaise with OPDP and APLB reviewers, and track review process metrics for continuous improvement. Collaborate across Regulatory Affairs, Medical, Legal, Commercial, and Compliance teams to develop compliant promotional strategies and materials, including global coordination. Requirements: Bachelor's in life sciences, minimum 4 years in drug/biologic regulatory affairs, with at least 2 years focused on advertising and promotion; knowledge of FDA regulations, enforcement trends, and global codes; strong communication, negotiation, and leadership skills. Preferred: advanced degree (e.g., PharmD, PhD, MS, JD), experience managing regulatory filings, RAC certification. HighValue: expertise in US prescription drug promotion, FDA compliance, global promotional material review, and cross-functional collaboration. WorkSetup: remote within the US; up to 20% travel.