Deputy Manager - Regulatory Affairs (API)

Key Responsibilities:

Drug Master File (DMF) Management

• Prepare, review, and submit DMFs in compliance with global regulatory

requirements including US (FDA), EU (ASMF and CEP), Canada, China, Korea, Brazil,

and emerging markets.

• Maintain and update DMFs throughout their lifecycle, including change filings and

regulatory correspondence.

Regulatory Strategy & Compliance

• Develop and implement regulatory strategies for generic synthetic, semi-synthetic,

and peptide APIs.

• Ensure all submissions meet statutory and regulatory standards across regions.

Deficiency Response Handling - Prepare responses to the deficiencies received from

customers and agency, ensuring clarity, completeness, and compliance with their

expectations.

Electronic Submissions - Prepare and submit dossiers using eCTD format via CDER