Associate Director, CMC
Core
Lead the China RA CMC team to deliver timely regulatory submissions and ensure compliance with external regulations and internal quality procedures.
Role type
Senior IC regulatory affairs manager (CMC)
Builds
CMC regulatory submissions for drug development and lifecycle management
Domain
Pharmaceutical regulatory affairs (CMC)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC Development, CMC Strategy, Policy Implementation, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions, Strategic Thinking, Team Management, Vendor Management
Preferred skills
Advanced degree in chemistry/biology, 5+ years R&D/regulatory experience, ICH guidelines knowledge, English/Chinese fluency
Technologies
None stated
Responsibilities
Manage team performance, training, and workload; collaborate cross-functionally to mitigate risks; deliver CMC submissions; provide technical support for specifications and inspections; engage with project teams on CMC needs; build networks with industry associations
Seniority
Senior, hands-on IC with team leadership
