:

- 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:

8–12 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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📌 Hiring for Manager / Senior Manager – Regulatory Affairs (API) (Hyderabad)
🏢 Hetero
📍 Hyderabad