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    Sr. Manager - Mumbai, India - KlinEra Global Services

    KlinEra Global Services
    KlinEra Global Services Mumbai, India

    1 week ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    The Sr. Manager, Regulatory Affairs will be responsible for overseeing regulatory activities related to clinical trials conducted by the clinical research organization. This position will play a crucial role in ensuring compliance with regulatory requirements and providing strategic regulatory guidance to internal teams and clients. The Sr. Manager, Regulatory Affairs will report to the Director of Regulatory Affairs.

    JOB RESPONSIBILITES:-

    • Manage regulatory activities for clinical trials conducted by the organization, including but not limited to INDs, NDAs, BLAs, IDEs, and CTAs.
    • Provide regulatory guidance and support to project teams and clients throughout the clinical trial lifecycle.
    • Review and assess clinical trial protocols, informed consent forms, and other regulatory documents for compliance with regulatory standards.
    • Prepare and submit regulatory documents to health authorities, including IND applications, amendments, annual reports, and regulatory agency correspondence.
    • Collaborate with cross-functional teams, including Clinical Operations, Quality Assurance, and Medical Affairs, to ensure regulatory compliance and timely execution of clinical trials.
    • Serve as the primary point of contact for regulatory agencies and participate in regulatory agency interactions, including meetings, teleconferences, and inspections.
    • Stay abreast of regulatory developments and changes in regulations, guidelines, and standards applicable to clinical research.
    • Provide regulatory training and guidance to internal staff and clients on regulatory requirements and best practices.
    • Assist in the development and implementation of regulatory strategies to support business objectives and client needs.
    • Contribute to process improvements and initiatives to enhance regulatory compliance and efficiency.
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