IRA - Asian and African Countries

2 days ago


Ahmedabad, Gujarat, India ZYDUS LIFESCIENCES LTD Full time ₹ 15,00,000 - ₹ 28,00,000 per year

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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