Manager, US Medical Ad/Promo Regulatory Review

Role: US Medical Ad/Promo Regulatory Review Manager, providing expert guidance on FDA regulations for prescription drug and biologic promotional materials. Objectives: ensure regulatory compliance of promotional content across assigned products or therapeutic areas, support development of marketing labeling, and act as a regulatory resource within cross-functional teams. Responsibilities: collaborate with Regulatory Affairs, Medical, Legal, and Commercial teams to interpret FDA guidance; review and evaluate promotional materials for compliance; assess labeling changes and their impact on advertising; chair promotional review meetings; and improve review processes through metrics and recommendations. Requirements: Bachelor's in life sciences, with 3+ years in regulatory affairs or related fields, including 1+ year specific to drug advertising and promotion; strong knowledge of FDA regulations; excellent communication and problem-solving skills. Preferred: advanced degrees (PharmD, PhD, MS, JD), RAC certification. High-Value: US-specific promotion regulatory oversight, biologics and prescription drugs, compliance with FDA advertising regulations, experience with multi-product therapeutic areas, and GxP familiarity. Work Setup: remote within the US; travel up to 20%, including possible international trips.