Regulatory Affairs

2 days ago

Mumbai Maharashtra, India Nuvvagen Bioscience (P) Ltd. Full time

Liaise with CDSCO, State FDA, DCGI, and port offices for various regulatory submissions and approvals.
- Handle post-approval changes, renewals, and life-cycle management of registered products.
- Respond to regulatory queries and deficiencies from authorities in a timely and compliant manner.
- Coordinate with QA, QC, R&D, Production, and other departments to collate and review technical documents.
- Review and maintain updated Product Information Files, dossiers, site master files (SMFs), and drug master files (DMFs).
- Ensure product labels and artworks comply with D&C Rules, FSSAI (if nutraceuticals), and other applicable standards.
- Keep abreast of regulatory updates, amendments, and circulars from CDSCO and other global regulatory bodies.
- Provide regulatory input in product development stages to ensure smooth approval pathways.

**Job Types**: Full-time, Permanent

Pay: ₹400,000.00 - ₹600,000.00 per year

**Education**:

- Bachelor's (required)

**Experience**:

- Microbiologist: 1 year (required)

Work Location: In person

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