Job Description

Department
IRA
Job posted on
Oct 30, 2025
Employment type
P-P8-Probationer-HO Executive

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.