Posted:2 weeks ago|
Platform:
Work from Office
Full Time
Role & responsibilities: 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. Preferred candidate profile: Candidate must have core International Regulatory Affairs experience in Latam and EU market can only apply. Candidate should have good technical job knowledge of EU and other regulatory. Should have good communication and interpersonal skills
Aculife Healthcare
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