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    • Executive/Sr. Executive Regulatory Operation- CTA - Mumbai - SUN PHARMA

    SUN PHARMA
    SUN PHARMA Mumbai

    1 month ago

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    Description
    Job Description:
    As a Regulatory Specialist, you will assume a critical role in the assigned specialty programs (NCE/BLA) and be responsible for regulatory operations activities.
    Key Responsibilities include:
    • Managing CTA applications across various regions including EU, LATAM, USA, Canada, and ROW
    • CTIS management and submission management
    • eCTD publishing of all modules and document management

    Strong understanding of current Global Regulatory filing requirements and eCTD /CTIS structure is essential.

    Collaboration and Planning:
    Collaborate with Strategists and coordinators to develop submission strategies and timelines. Prepare Regulatory Management Plans and Submission content plans for CTA submissions.

    Lifecycle Management:
    Manage the lifecycle of CTA submissions, overseeing in-house and outsourced activities. Ensure accurate and timely input of data during Clinical Trial Application submission and notification processes.

    Archival and Process Improvement:
    Archive necessary submissions and documents, and assist in defining, developing, and implementing processes to meet evolving CTIS needs. Implement best practices and participate in process improvements/enhancements.

    Metrics and Reporting:
    Track and generate metrics as requested by the Functional Head from time to time.

    Required Qualifications:
    Master's or Bachelor's degree in Pharmacy (M. Pharma/B. Pharma)

    Essential Skills:
    Regulatory Affairs, Submission, eCTD, CTA, CTIS

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