(Sr.)Manager, CMC Regulatory Affair, R&D, Shanghai/Beijing
Core
Develop and execute global regulatory strategies for assigned programs, manage submissions, and support health authority interactions for CMC requirements.
Role type
Senior Manager, CMC Regulatory Affairs
Builds
Global regulatory strategies and compliant submissions for assigned pharmaceutical programs
Domain
Life Sciences / Pharmaceutical Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory strategy development, CMC requirements expertise, Health authority negotiation, Project team leadership, Regulatory submission management, Risk mitigation
Preferred skills
Cross-functional alignment, Mentoring junior staff, Complex information communication
Responsibilities
Develop and execute global regulatory strategies, Collaborate with regional counterparts to align strategies, Create and submit compliant regulatory documents, Manage regulatory submissions, Support health authority interactions, Ensure accurate global reporting of program status, Lead and mentor junior staff
