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    Manager - International Regulatory Affairs - Pharma - Mumbai, India - Domnic Lewis International

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    Description
    MANAGER-REGULATORY AFFAIRS INTERNATIONAL Preparation and reviewing of CTD and ACTD dossier.

    • Coordination with Plant and R&D to collect inputs required for Regulatory Submission.
    • Coordination with plant for Regulatory compliances.
    • Timely achievement of monthly plan & timely query response.
    • Gap Analysis/Updation of Master data.
    • Review of Change Controls, Stability Protocol, Clinical Trial Protocols & Artworks.
    • Gather feedback from all the countries for respective variation, and ensure timely submission.
    • Handle renewals.
    • Updating Master data.
    • Followups with plant for documentation regularly and review meetings.
    • Tracking and reviewing document requirements for upcoming new filings in ROW and Emerging markets

    Knowledge and skills:
    - eCTD, CTD, Validation, ICH requirements, USFDA Filings,WHO Prequalification, MCC South Africa for Biological and Biotech 6-8 years

    )


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