Copy of Senior Manager Regulatory Affairs US Advertising and Promotion
Core
Senior Manager leading US advertising and promotion regulatory compliance for pharmaceutical products, ensuring materials meet FDA and industry guidelines while influencing the regulatory environment.
Role type
Senior Manager, Regulatory Affairs (Advertising & Promotion)
Builds
Compliant advertising and promotional materials for pharmaceutical products
Domain
Pharmaceuticals / US Regulatory Affairs
Deliverable
product features
Required skills
US regulatory affairs expertise, advertising and promotion compliance, FDA guidance interpretation, Code of Federal Regulations knowledge, PhRMA Guiding Principles, strategic planning, team leadership, stakeholder management, cross-functional collaboration
Preferred skills
PharmD degree, management experience, complex matrix environment navigation, negotiation skills
Technologies
None stated
Responsibilities
Monitor and disseminate government and industry policy changes impacting regulatory operations; represent the department in trade associations; oversee staff ensuring advertising materials comply with CFR, FDA guidance, and PhRMA principles; develop and guide implementation strategies for promotional activities; manage direct reports including training and mentoring; present information to cross-functional groups and deliver difficult messages to commercial organizations
Seniority
Senior Manager, hands-on leadership
