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 providing strategic regulatory guidance to enable business growth.
Role type
Senior leadership regulatory affairs head (advertising & promotion)
Builds
Compliant promotional strategies, policies, SOPs, and risk mitigation frameworks for pharmaceutical products
Domain
Healthcare / Pharmaceuticals / US Regulatory Affairs
Deliverable
client delivery
Required skills
US FDA promotional regulations expertise, strategic regulatory leadership, cross-functional collaboration, team management, risk mitigation strategy, regulatory committee leadership, promotional review process expertise
Preferred skills
Advanced degree in scientific discipline (MS, PharmD, MD), experience with PSMR workflows
Technologies
Microsoft Office Suite
Responsibilities
Develop and implement A&P regulatory strategies and compliance frameworks; Partner with medical affairs, legal, and marketing teams to ensure material accuracy; Serve as primary contact with FDA OPDP for submissions and enforcement responses; Review and approve promotional materials for compliance with labeling; Build efficient review processes and optimize MLR/PRC workflows; Manage a 4–5 member team including coaching and performance management; Monitor FDA, FTC, and SEC enforcement trends to guide business strategy
Seniority
Senior, hands-on IC with management responsibilities
