Senior Manager Regulatory Affairs US Advertising and Promotion
Core
Senior Manager leading Regulatory Affairs for US Advertising and Promotion, ensuring compliance with FDA and other regulations for pharmaceutical products.
Role type
Senior Manager, Regulatory Affairs (Advertising & Promotion)
Builds
Compliant advertising and promotional materials for pharmaceutical products
Domain
Pharmaceuticals / Regulatory Affairs
Deliverable
product features
Required skills
Regulatory affairs expertise, FDA guidance knowledge, Code of Federal Regulations (CFR) knowledge, PhRMA Guiding Principles knowledge, strategic planning, team management, stakeholder management, cross-functional collaboration, policy analysis, training and mentoring
Preferred skills
PharmD degree, management experience, negotiation skills, complex matrix environment experience
Technologies
None stated
Responsibilities
Capture and disseminate government and industry regulatory activities impacting pharmaceutical policies; Draft and finalize comments to regulators and trade associations; Oversee operations productivity and development of regulatory staff; Develop and guide implementation strategies for promotional activities; Ensure departmental training and compliance with advertising and promotion regulations; Present information to cross-functional groups; Establish relationships with key stakeholders (Marketing, Medical, Legal, etc.)
Seniority
Senior, hands-on IC with management responsibilities
