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Aculife Healthcare
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Regulatory Affairs Officer

Regulatory Affairs Officer

Aculife Healthcare

1 - 3 years

1 - 4 Lacs

Ahmedabad

Posted:1 month ago| Platform:

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Skills Required

Regulatory Affairs Europe Parenteral Latam Anesthesia Critical Care Suspension Injectables Latin America

Work Mode

Work from Office

Job Type

Full Time

Job Description

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

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Regulatory Affairs Officer