Manager Regulatory Affairs, Global Regulatory Strategy US & Canada - Hybrid
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
Manager, Regulatory Affairs (Global Regulatory Strategy)
Builds
Regulatory submissions and strategies for pharmaceutical products
Domain
Life Sciences / Pharmaceuticals / US & Canada Regulatory
Required skills
US and Canada regulatory strategy implementation, Health Authority (FDA) liaison, regulatory submission preparation and review, cross-functional negotiation, interpretation of government regulations and guidances
Preferred skills
Global regulatory experience, advanced degree, 2-3 years in pharmaceutical regulatory activities
Technologies
None stated
Responsibilities
Serve as Health Authority liaison with FDA for routine communications and application reviews; advise internal customers on Regulatory/FDA issues; prepare and review regulatory submissions; recommend project changes based on regulatory knowledge; present regulatory information to cross-functional areas
Seniority
Manager, hands-on IC