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    Executive, Regulatory Affairs - Gurugram, India - Johnson & Johnson

    Johnson & Johnson
    Johnson & Johnson Gurugram, India

    1 week ago

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    Description

    Job title:
     Executive, Regulatory Affairs


    Overall purpose of job:


    • Regulatory compliance for the Medical Devices marketed by Johnson & Johnson MedTech India
    • To maintain the Life cycle management of the product registered by Johnson & Johnson
    • Coordinate with internal stakeholders to Developed regulatory strategies and mitigate interdependencies of overlapping projects to successfully submit application.

    Essential duties and responsibilities:


    • Draft, review and submission of Regulatory filings (Re-registrations/ New Registrations/ Legal-Physical manufacturer transfer) for India market.
    • Draft, review and submission of other Regulatory submissions (Query responses, Corrections fillings, miscellaneous notifications regarding post registration regulatory lifecycle management) for India market in accordance with applicable regulations and relevant guidelines.
    • Draft cover letters for Regulatory communications/ submissions depending on level of regulatory knowledge/expertise.
    • Update and live maintenance of business plan in sharepoint for assigned franchises/ licenses.
    • Assist in the preparation of technical presentations/ meetings with regulator.
    • Gathers and assembles information, prepares documents for New Product applications/Renewal Applications/Change Notifications/Response to Regulatory Agencies questions in accordance with regulations and relevant guidelines.
    • Maintain the changes to the Regulations/Products/Sites and make necessary submission to maintain compliance to Country Regulations (Lifecycle management)
    • Coordination with internal stakeholders ensuring compliant lifecycle management of responsible products/franchises.
    • Maintain the changes to the Regulations/Products/Sites and make necessary submission to maintain compliance to Country Regulations
    • Maintenance of RA database for the responsible franchises in MDRIM tool.
    • Ensuring timely completion of received change assessment within due timeline and provide feedback to source RA team through email/other portals.
    • Creation and maintenance of Product Registrations request Form (PRRF) for any registration activities under responsible franchises/ licenses and Change Controls for any product discontinuation/ changes as per defined procedure.
    • Ensure on time archival of regulatory submission documents.
    • Understand complaint & adverse event reporting responsibility and report such events within 24 hours of becoming aware.
    • Other assignment identified and assigned by Supervisor/ management- time to time.

    Special requirements:


    • Knowledge of Medical Device Rule 2017 and Drugs and Cosmetics Act
    • Knowledge in the international regulations of Medical Devices in US and EU
    • Excellent proficiency with software tools

    Job location:

    Gurgaon, Haryana- India
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