Requirements: 5-7 Years of core regulatory experience for Finished Product from reputed Pharma company with sound knowledge of New Product Submissions, Deficiency Response, Post Approval Variations & Lifecycle Management.

Prior experience of handling of Middle East region (Saudi Arabia, UAE, Oman, Jordan, Qatar etc.) will be 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 and review 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 current 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 DMF, GMP certificate etc. for regulatory actions.

Job Snapshot

Updated Date

11-08-2026

Job ID

JOB10958

Department

IRA

Location

Corporate Office|Corp. Office, Ahmedabad, Gujarat, India

Experience

5 - 7 Years

Employee Type

C-C8-Confirmed-HO Executive

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