
Compiler
5 days ago
Division
- IRA
- Job posted on
- Aug 26, 2025
- Employee Type
- P-P8-Probationer-HO Executive
- Experience range (Years)
- 0 - 0
- Compilation and review of new registration dossiers as per country requirements.
- 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 ROW 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 review various artworks & comments for ongoing commercial supply & products for the new launch.
- To prepare and maintain various registration Data base & updating at Central Depository
- Compilation and Review of commercial and supporting documents
- To coordinate with GDSO & vendor to get DME, GMP certificate etc. for filing purpose.
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