Senior Manager, Regulatory Affairs US Advertising and Promotion - Immunology - Hybrid
Core
Senior Manager leading Regulatory Affairs for US Advertising and Promotion in Immunology, ensuring compliance with FDA and industry guidelines while influencing regulatory policy.
Role type
Senior Manager, Regulatory Affairs (Advertising & Promotion)
Builds
Compliant advertising and promotional materials for immunology products
Domain
Pharmaceutical / Immunology / US Regulatory Affairs
Deliverable
client delivery
Required skills
US Regulatory Affairs (Advertising & Promotion), FDA guidance interpretation, Code of Federal Regulations (CFR) knowledge, PhRMA Guiding Principles, strategic policy analysis, team management, cross-functional stakeholder engagement
Preferred skills
PharmD degree, management experience, complex matrix environment navigation, negotiation skills
Technologies
None stated
Responsibilities
Monitor and disseminate government/industry regulatory policy changes; represent department in trade associations; oversee staff ensuring advertising compliance with FDA/CFR/PhRMA; develop implementation strategies for promotional activities; manage direct reports and mentor staff; present information to cross-functional groups
Seniority
Senior, hands-on IC with management responsibilities