Director, Global Regulatory Affairs Advertising & Promotion

Role: Director of Global Regulatory Affairs Advertising and Promotion, providing strategic and operational leadership for commercial regulatory activities related to prescription drug advertising and promotion. Responsibilities: serve as subject-matter expert, liaise with FDA/CDER/OPDP, oversee or author regulatory submissions, guide promotional campaigns, maintain current regulatory knowledge, and develop process improvements. Requirements: Bachelor's or higher in a scientific field; 10-12+ years in Regulatory Affairs, with extensive experience reviewing promotional materials for prescription drugs or biologics, including direct FDA OPDP interaction. Preferred: knowledge of USPI/global labeling, cross-functional team experience, and international marketing laws. High-Value: expertise in US prescription drug advertising regulations, FDA interactions, and global promotional compliance. Work Setup: high-paced, dynamic environment with some travel, potentially outside standard hours.