Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada
Core
Develop and implement US and Canada regulatory strategic and tactical planning (RSTP) for assigned on-market and in-development products to enable commercialization.
Role type
Senior Manager, Regulatory Affairs (Global Reg Strategy)
Builds
Regulatory strategies and submissions for pharmaceutical products
Domain
Pharmaceuticals / Life Sciences
Required skills
US and Canada government regulations interpretation, regulatory submission preparation, FDA meeting coordination, cross-functional negotiation, strategic planning, data gathering for filings
Preferred skills
Global regulatory experience, advanced degree, industry certifications
Technologies
None stated
Responsibilities
Develop and execute regulatory strategies for therapeutic areas; Serve as Health Authority liaison and coordinate FDA meetings; Prepare and review regulatory submissions; Advise internal stakeholders on regulatory issues; Interpret government regulations and corporate policies; Present regulatory information to cross-functional teams
Seniority
Senior Manager, hands-on IC with strategic oversight