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    • Manager Regulatory Affairs - Mumbai - Abbott

    Abbott
    Abbott Mumbai

    1 week ago

    Default job background
    Description

    Job Description:

    Minimum Education:

    M. Pharm/B. Pharm

    Minimum Experience Required:

    8-10 years of experience in FSSAI filings (mandatory) and drug filings

    Regulatory Expertise for New Product Introduction:

    • Ensure compliance with all applicable national regulations, guidelines, codes, and policies related to FSSAI, Ayurvedic, and Drug products.
    • Review DTM (Draft Text Matter) for FSSAI products.
    • Review composition (RDA limits), health claims on product labels for FSSAI and AYUSH range of products.
    • Liaison with regulatory authorities for various matters related to FSSAI products.
    • Track and review new regulations, including FSSAI and AYUSH Guidelines/Regulations, and communicate the impact on new products and existing product portfolios to Cross-functional Teams.
    • Review and approval of promotional inputs for Nutra and Ayurvedic products.
    • Maintenance of FSSAI licenses, including submission of annual returns to the Regulatory authority.
    • Provide technical inputs on review of CMC data for Central (CDSCO) and State dossiers related to new products under development.
    • Liaison with other departments, such as Learning & Development, Quality, Supply Chain, Project Management, etc., to deliver high-quality dossiers, in accordance with business priorities.
    • SUGAM filing for CDSCO (Central Drugs Standard Control Organization) new drug products starting from initial application until approval.
    • Address queries from CDSCO & FSSAI on submitted applications.
    • SEC recommendation tracking, analysis, and presentation to respective affiliates.
    • Provide Regulatory Support for on-time FSSAI, Ayurvedic & Drug Product new product launches.
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