Senior Manager, Regulatory Affairs
Core
Develop and execute regulatory strategies for oncology product registration, approval, and lifecycle management in China.
Role type
Senior Manager, Regulatory Affairs
Builds
Oncology product registrations and approvals in China
Domain
Pharmaceutical industry, Oncology, China regulatory landscape
Required skills
Regulatory strategy, NMPA interactions, Product lifecycle management, Cross-functional leadership, Regulatory intelligence, Quality compliance
Preferred skills
Oncology therapeutic area, Multinational pharma experience, Advanced degree (Master's/PhD)
Technologies
NMPA systems, Regulatory submission platforms
Responsibilities
Develop regulatory strategies for oncology products, Lead NMPA application preparation and submission, Manage post-approval lifecycle activities, Monitor regulatory developments and policy changes, Collaborate with global and local cross-functional teams, Support audits and inspections
Seniority
Senior, hands-on IC with leadership responsibilities