Ira - Asian And African Countries (Gujarat)

Ira - Asian And African Countries (Gujarat)

11 Aug
|
Zydus Lifesciences
|
Gujarat

11 Aug

Zydus Lifesciences

Gujarat

Division IRA Job posted on Oct 04 2025 Employee Type P-P7-Probationer-HO Staff Experience range Years 0 - 0 Compilation and review of new registration dossiers in CTD or eCTD format as per country requirements Review of Technical Documents ODMF Product Development Report BMR BPR Analytical Method Validation Report Specification-STP Stability Report BE Study Report etc for the submissions Compilation of deficiency responses Preparation and submission of variation packages for post approval changes Communication and follow up with overseas regulatory team agent distributors to ensure timely filing of new submission or variation Review of artworks comments for ongoing commercial supply products for the recent launch Preparation and maintenance of various registration Data base updating at Central Depository Compilation and Review of commercial documents for annual updates to the agencies Co-ordinate with supplier through dedicated sourcing team to get DME GMP certificate etc for regulatory actions

📌 Ira - Asian And African Countries (Gujarat)
🏢 Zydus Lifesciences
📍 Gujarat

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