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 current 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) (Telangana)
🏢 Hetero
📍 Telangana