Regulatory Affairs Liaison (Associate Director)
Core
Oversees regional regulatory strategy for product development, registration, and lifecycle management across clinical, CMC, and risk management domains.
Role type
Associate Director, Regulatory Affairs
Builds
Regional regulatory strategies and health authority registration approvals
Domain
Pharmaceuticals, Regulatory Affairs
Required skills
Regulatory strategy, Health Authority registration, NCE lifecycle management, RTQ management, regional policy development, cross-functional collaboration, project prioritization, strategic communication
Preferred skills
Asia Pacific regulatory experience, Clinical Research knowledge
Technologies
Regulatory databases, submission systems
Responsibilities
Serve as single point of contact for products with countries and HQ, lead identification of regional submission elements, manage execution of Health Authority Response to Questions, monitor and communicate strategic program issues, align portfolio strategy with stakeholders, contribute to regional regulatory policy issues
Seniority
Senior, hands-on IC