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  • Team Member - Mumbai, India - Cipla

    Cipla
    Cipla Mumbai, India

    3 weeks ago

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    Description

    Job Description

    The Corporate Affairs Division of {company} is seeking a highly skilled and experienced Regulatory Affairs professional to support the coordination and submission of regulatory dossiers for product approval in India.

    Key Accountabilities:

    1. Track the status of product approvals in India (DCGI) and globally, as well as CDSCO banned list products and their impact on our brands.
    2. Collaborate with internal stakeholders to ensure timely regulatory submissions and compliance with regulatory requirements.
    3. Actively participate in discussions and planning with cross-functional teams to ensure regulatory timelines are met.
    4. Track DTAB/DCC/SEC meetings and share intelligence related to projects and company initiatives.
    5. Analyze and share market intelligence data and prepare regulatory monitor reports capturing key regulatory developments on a monthly basis.
    6. Coordinate dossier preparation and submission, ensuring reduction of repeated queries and reducing approval timelines.

    Dimensions:

    • Effective coordination with internal stakeholders to support timely regulatory approvals.
    • Streamlining processes to reduce delays and improve project outcomes.

    Requirements:

    • Relevant work experience: Minimum 5-10 years in Regulatory Affairs.
    • Technical knowledge of India Regulatory landscape.
    • Inter-personal skills and ability to communicate effectively with cross-functional teams.

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