China RA manager

CSL • Shanghai, Shanghai, China • Posted June 25, 2026

Location Shanghai, Shanghai

Job Type Full time

Category Operations Specialties Managers

Posted June 25, 2026

Responsibilities:
1、Regulatory Submission Preparation & Execution 
Leadthe preparation, review, and compilation of high-quality regulatory dossiers (e.g., CTD/eCTD format) for product registrations, variations, renewals, and other regulatory filings to NMPA and other global health authorities. 
Ensure accuracy, consistency, and compliance of submission documents with regional guidelines, company SOPs, and global regulatory standards. 
Coordinate with cross-functional teams (R&D, CMC, Clinical, Quality, Medical Affairs) to collect, validate, and consolidate technical and clinical data for regulatory submissions. 
Manage submission timelines, track deliverables, and resolve document-related issues to ensure on-time filing.
2、Regulatory Compliance & Lifecycle Management 
Monitor and maintain regulatory compliance of registered products, including tracking license renewals, post-approval commitments, and periodic safety update reports (PS...
            

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