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Vadodara

    Research Scientist - Vadodara, India - SUN PHARMA

    SUN PHARMA
    SUN PHARMA Vadodara, India

    Found in: Talent IN C2 - 2 days ago

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    Description
    Job Summary
    Regulatory submission of new products, variations, response to queries and Life cycle management for Nepal and Myanmar
    markets through preparation of quality dossiers enabling timely approvals.
    Area Of Responsibility

    1.


    New submissions:
    a. Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions.
    b. Review documents (Development report, scale up report, specification, stability protocol), artworks etc.
    before initiation of Exhibit batches for adequacy.

    2.


    Approval :
    Review & prepare response to deficiency enabling approval of products filed to regulatory agency.
    3.

    Lifecycle management for drug formulations:
    a. Prepare and review variations as per the country specific requirements to support approval of changes such as API
    vendor changes/changes in ROS/test parameters; DF site changes; harmonization of products etc.

    4.


    Regulatory compliance:
    a. Prepare, Review and circulate approval package with product history sheet to stake holders upon receipt of approval and update
    the same based on queries and variations.
    b. Ensure reposition of comprehensive product information into central repository
  • Reliance Industries Limited

    Sr. Research Scientist

    Found in: Talent IN C2 - 5 days ago

    Reliance Industries Limited Vadodara, India

    Job Responsibilities : · . · Manage a set of assigned research tasks including benchmarking of targets, compilation of research data related to the assigned research and development processes while meeting time targets and ensuring regulatory compliances including ISO, NABL and ...