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 / US Regulatory Affairs
Deliverable
client delivery
Required skills
US Regulatory Affairs expertise, Advertising and Promotion compliance, FDA guidance interpretation, PhRMA Guiding Principles knowledge, Government/industry policy analysis, Staff management and mentoring, Cross-functional stakeholder management
Preferred skills
PharmD degree, Management experience, Complex matrix environment navigation, Negotiation skills
Technologies
None stated
Responsibilities
Monitor and disseminate government/industry policy changes impacting regulatory operations; Represent department in 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 regulations; Present information to cross-functional groups; Deliver difficult messages to commercial organizations; Establish relationships with key stakeholders (Marketing, Medical, Legal, etc.)
Seniority
Senior, hands-on IC with management responsibilities