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    - RA - Mumbai, India - BEST-FIT Recruitment Riders

    BEST-FIT Recruitment Riders
    BEST-FIT Recruitment Riders Mumbai, India

    12 hours ago

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    Description

    Job Profile:

    • Responsible for collection & preparation of plant-level documents for regulatory submission.Product Registration as per registration guidelines of different countries and regulatory submission.
    • Prepare and submit variations to authorities. Follow up on submissions, timelines, and approvals, with the concerned person.
    • Well versed with CTD formats and dossier preparation.
    • Ensuring samples are sent timely and coordinating with a concerned person for submission, getting the receipts, and follow-up on the registrations.
    • Checking COAs before dispatch of Commercial Orders.
    • Application of Product Permissions, COPPs, and coordination for the addition of New Products in WHO GMP List.
    • Checking of Artwork, Leaflets of both International and Domestic Supplies.
    • Participate in writing and updating SOP / Work Instructions and process improvements.
    • Travel to Manufacturing Units during the Audit by External Agencies.

    Desired Profile:

    • B. Pharm / M. Pharm with 4.0 to 7.0 yrs of experience in Regulatory Affairs in Formulation with growing Pharma in Semi Regulated / ROW markets.
    • Should have good understanding of Regulatory Affairs life cycle for Solid Oral, Parenteral & Topical Formulations.
    • Candidate must have very good writing & communication in English.
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