5 - 7 years
5 - 8 Lacs
Posted:1 week ago|
Platform:
Work from Office
Full Time
• Compilation and review of registration dossiers as per Country specific guidelines and requirements.
• Specific experience required for Latam American market including Brazil, Mexico. Should have to work for EU market and hands on experience about the submission Management system. • Review of all Technical Documents (DMF, Product Development Report, BMR, BPR, Analytical Method Validation Report, Specification-STP, Stability Report, BE Study Report etc.)• Compilation of deficiency responses of new product submission and Backlog dossier •To review the proposal for any post-approval changes as per the current regulatory guidance.• To prepare and submit the variation for post approval changes.• To communicate and follow up with overseas regulatory team /agent/ distributors to ensure timely filing of new submission or variation.• To review various artworks & comments for ongoing commercial supply & products for the new launch.• To prepare and maintain various registration Data base & updating at Central Depository
Candidate must have 5 to 7 years of core IRA experience .
•Candidate should have good technical job knowledge .•Should have good communication and interpersonal skills.
Aculife Healthcare
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