IRA Brazil

Requirements:

• 8-10 Years of core regulatory experience for Finished Product with sound knowledge of New Product Submissions, Deficiency Response, Post Approval Variations & Lifecycle Management.
• Prior experience of handling of Brazil (ANVISA) and other Latin American markets is essential.

• 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 new submission or variation.
• Review of artworks & comments for ongoing commercial supply & products for the new launch.
• Preparation and maintenance of various registration database & 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.

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