Job Description:

Responsible for regulatory submissions and lifecycle management of API products for the China market .
Prepare, compile, review, and submit China DMF dossiers in line with NMPA regulatory requirements.
Handle new registrations, amendments, renewals, and annual maintenance of regulatory filings.
Review technical documents including CTD modules, manufacturing process, specifications, analytical methods, validation reports, impurity data, and stability reports.
Coordinate with R&D, QA, QC, Production, and Manufacturing teams to obtain and verify submission documents.
Draft and submit responses to regulatory deficiencies, customer queries, and authority observations within timelines.
Track changes in China regulatory guidelines and ensure timely implementation across all registered products.
Liaise with Chinese agents, customers, and regulatory authorities to facilitate approvals and resolve regulatory issues.
Maintain regulatory databases, submission trackers, and ensure compliance with internal and external audit requirements.
Support business development by providing regulatory assessments for new API products and market expansion opportunities.

Qualification: B. Pharm / M. Pharm / M.Sc. (Chemistry)
Experience: 812 years in API Regulatory Affairs with hands-on experience in China DMF filings, NMPA regulations, CMC documentation, deficiency responses, and lifecycle management .

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Manager / Senior Manager Regulatory Affairs (API)

Job Description

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