China Regulatory CMC Lead
Core
Senior in-country Regulatory CMC leader setting China CMC regulatory direction, interpreting evolving regulations, and translating them into enterprise-level strategies across development, registration, and lifecycle management.
Role type
Senior IC regulatory CMC lead (China)
Builds
China-specific regulatory pathways, filing requirements, and cross-functional dependencies for small molecules, biologics, ASOs, and drug-device combinations.
Domain
Pharmaceutical regulatory affairs (China)
Required skills
CMC regulatory strategy, health authority engagement (CDE/NMPA), lifecycle management, cross-functional leadership, risk assessment, regulatory intelligence
Preferred skills
Advanced scientific degree, people management, global matrix leadership
Technologies
CDE, NMPA, QOS, Module 3
Responsibilities
Set China Regulatory CMC strategy and provide authoritative local expertise; Lead the China portfolio through a shared local–global operating model; Shape regulatory intelligence, external engagement, and organizational capability; Provide enterprise and cross-functional China PO&T leadership
Seniority
Senior, hands-on IC