Ira Row

2 weeks ago

Ahmedabad Gujarat, India Zydus Group Full time

Division
- IRA
- Job posted on
- Oct 30, 2025
- Employee Type
- P-P8-Probationer-HO Executive
- Experience range (Years)
- 2 years - 5 years

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.

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