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Regulatory Affairs Executive
1 week ago
Regulatory Affairs Executive (01 Person):
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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