Sr. Director/Executive Director, Advertising and Promotion

Advanced degree in a scientific discipline (PharmD, PhD, or MD). 15+ years of progressive regulatory experience in the biopharmaceutical industry. At least 10 years focused on pharmaceutical advertising and promotion. Demonstrated expertise in regulatory systems (e.g., Veeva Vault, RIM). Experience developing process governance frameworks (SOPs, WIs, desk procedures). Track record of leading or enabling digital transformation or AI integration within regulatory functions. Exceptional leadership, communication, and influencing skills.

Lead regulatory advertising and promotion strategies for pre- and post-marketed products. Serve as primary reviewer on promotional Medical/Legal/Review (MLR) committees. Partner with Commercial and Legal leaders on promotional initiatives and FDA requirements. Interpret FDA regulations and guidance for promotional materials. Oversee review and approval of promotional materials. Provide training on regulatory promotional compliance. Establish SOPs for regulatory advertising and promotion. Serve as regulatory contact for FDA OPDP. Prepare and lead responses to FDA inquiries. Monitor enforcement trends and adjust strategies. Hire, coach, and mentor regulatory professionals.