Sr Executive
1 week ago
Please share your resume at
Role & responsibilities
- Preparation, compilation, and review of Drug Master Files (DMFs) and Active Substance Master Files (ASMFs) for submission to various regulatory authorities (USFDA, EDQM, TGA, PMDA, etc.).
- Handle query responses from global regulatory agencies and ensure timely and accurate replies.
- Coordinate with R&D, Quality Assurance, Quality Control, and Production teams for regulatory data collation.
- Review of technical documents such as specifications, analytical methods, process descriptions, and stability data.
- Support in the preparation of Annual Product Reviews and Post-Approval Changes.
- Maintain and update regulatory databases and tracking systems.
- Ensure compliance with ICH, USFDA, and EU guidelines for API documentation.
- Support audits and inspections by regulatory authorities.
- Ensure regulatory compliance throughout the product lifecycle.
- Strong knowledge of API regulatory guidelines (USDMF, EDMF, CEP, WHO, etc.).
- Understanding of CTD format and global submission requirements.
- Good communication and coordination skills.
Preferred candidate profile
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