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: 8–12 years in API Regulatory Affairs with hands-on experience in
China DMF filings, NMPA regulations, CMC documentation, deficiency responses, and lifecycle management.
