Regulatory Affairs Executive

1 month ago


Vadodara Gujarat, India Krosyl Pharmaceuticals Full time

**Qualification**: B. Pharm / M. Pharm-RA

**Experience**: 2 to 3 Years

**Description**:

- Preparation and review the dossier of as per current prescribed guidelines of the respective regulatory authority.
- Well versed with the guidelines of ICH and other regulatory.
- Preparation of documents for COPP, FSC, and other legal documents including product permission
- Preparation of registration documents as per ACTD, CTD, country format / Review / Preparation & Compilation
- Preparation of text matter and checking of artworks.
- Should coordinate with the factory for samples, working standards, document data, license related documents.
- Should have knowledge with regard to checking samples.
- Courier of documents and samples to the respective customer.
- Maintaining status and record of dossiers, and samples legal documents.



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