Regulatory Affairs Executive

1 week ago


Vadodara, Gujarat, India Krosyl Pharmaceuticals Full time

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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