IRA - Asian and African Countries

2 weeks ago

Ahmedabad, Gujarat, India zydus lifesciences Full time ₹ 6,00,000 - ₹ 12,00,000 per year
Job Description
  • 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.

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

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