
Compiler
1 week ago
Division
IRA
Job posted on
Sep 11, 2025
Employee Type
P-P8-Probationer-HO Executive
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 new 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.
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