Regulatory Affairs

• Preparation and filing of new drug applications (NDA), abbreviated new drug applications (ANDA) for submission to regulatory authorities.
• 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