Assistant Manager

7 days ago


Patancheru, Telangana, India MSN Group Full time ₹ 5,00,000 - ₹ 15,00,000 per year

Key Responsibilities:

  1. Regulatory Support & DMF Filing:

  2. Support the Regulatory Affairs team in the preparation, compilation, and submission of Drug Master Files (DMFs) for new products across different regulatory agencies.

  3. Coordinate with cross-functional teams (QA, QC, Production, R&D) for timely data collection and documentation.

  4. Regulatory Deficiencies & Queries:

  5. Review, analyze, and address regulatory deficiencies raised by authorities within stipulated timelines.

  6. Prepare clear and concise responses to regulatory queries in coordination with internal departments.

  7. Assessment & Amendments:

  8. Prepare and review country-specific regulatory assessments and amendments based on current regulatory guidelines and product variations.

  9. Ensure compliance with regional submission formats and documentation requirements.

  10. Customer Communication:

  11. Address customer queries related to DMF and regulatory documentation promptly and professionally.

  12. Provide technical support to customers for regulatory submissions and clarifications.

  13. Regulatory Compliance:

  14. Maintain up-to-date knowledge of global regulatory guidelines, compliance requirements, and submission procedures.

  15. Support audits and inspections by ensuring accuracy and completeness of regulatory documentation.


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