IRA ROW

1 week ago

Ahmedabad, Gujarat, India zydus lifesciences Full time ₹ 5,00,000 - ₹ 15,00,000 per year
Job Description
  • Review of Technical Documents (EDMF, Product Development Report, BMR, BPR, Analytical Method Validation Report, Specification-STP, Stability Report, BE Study Report etc.)
  • Compilation and review of dossiers as per requirements for Countries.
  • Compilation of deficiency responses of new product submission.
  • To prepare and submit the variation for post approval changes.
  • To communicate and follow up with overseas regulatory team /agent/ distributors to ensure timely filing of new submission or variation.
  • To prepare and maintain various registration Data base & updating at Central Depository.
  • Compilation and Review of commercial and supporting documents.
  • To Review and Approve Change Control Activity- Action item Closure in Track wise System.
  • To Review and Approve PVP-PVSR in Validator System.
  • To Compile APQR for Moraiya Plant every Month.
  • To Dispatch Samples according to filing Plan when required by Regulatory Markets.
  • To arrange documents for Deficiency response, Dossier filing, Tender Business and renewal Dossier filing on time. (Plants- Moraiya- SEZ-Biologics-Topical-ZRC-LL).
  • To do timely Signing for all documents generated from PTC and Other plants as mentioned above.
  • Maintaining Sample Sheet for various markets as defined as per Dossier filing plan.

Locations: Corporate Office | Corp. Office, Ahmedabad, Gujarat, India

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