
Ira - Asian and African Countries
6 days ago
Division
- IRA
- Job posted on
- Sep 11, 2025
- Employee Type
- P-P8-Probationer-HO Executive
- Experience range (Years)
- 0 - 0
**Requirements**: 5-7 Years of core experience in Finished Product Regulatory Affairs with sound knowledge of New Product Submissions, Deficiency Response, Post Approval Variations & Lifecycle Management.
Having experience in the Asian as well as Africa countries will be considered as an added advantage.
**Key Job Role**:
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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