Senior Manager RA US Advertising and Promotion - Hybrid
Core
Senior Manager leading Regulatory Affairs for US Advertising and Promotion in Neuroscience, ensuring compliance with FDA and industry guidelines while influencing regulatory policy.
Role type
Senior Manager, Regulatory Affairs (Advertising & Promotion)
Builds
Compliant advertising and promotion materials for neuroscience products
Domain
Pharmaceutical / Neuroscience / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory affairs expertise, FDA guidance knowledge, Code of Federal Regulations (CFR) compliance, PhRMA Guiding Principles, strategic planning, team management, stakeholder engagement, policy analysis
Preferred skills
PharmD degree, management experience, negotiation skills, complex matrix environment experience
Technologies
None stated
Responsibilities
Monitor government and industry regulatory changes impacting pharmaceutical policies; represent department in trade associations; oversee operations productivity and development of regulatory staff; guide implementation strategies for promotional activities; ensure departmental training and compliance with advertising regulations; present information to cross-functional groups; manage direct reports and assist in their development and mentoring
Seniority
Senior, hands-on IC with management responsibilities