Head of US Regulatory Affairs Advertising and Promotion, Global Regulatory Affairs
Core
Senior leadership role ensuring US advertising and promotion compliance for pharmaceutical products while enabling compliant business growth.
Role type
Senior leadership regulatory affairs head (pharmaceutical advertising)
Builds
Compliant promotional strategies and review workflows for pharmaceutical products
Domain
Healthcare / Pharmaceutical Regulatory Affairs
Required skills
US FDA promotional regulations expertise, strategic regulatory leadership, cross-functional collaboration, risk mitigation, team management, regulatory committee leadership, analytical skills
Preferred skills
Advanced degree in scientific discipline (MS, PharmD, MD), experience with PSMR processes
Technologies
Microsoft Office Suite
Responsibilities
Develop and implement A&P regulatory strategies; Partner with medical affairs, legal, and marketing teams; Serve as primary contact with FDA OPDP; Review and approve promotional materials; Build efficient review processes; Manage a 4–5 member team; Monitor FDA, FTC, and SEC enforcement trends
Seniority
Senior, strategic leadership with team management