Jobs

    Senior Officer-Regulatory Affairs - Goa, India - COLORCON ASIA PRIVATE LIMITED

    COLORCON ASIA PRIVATE LIMITED
    COLORCON ASIA PRIVATE LIMITED Goa, India

    3 hours ago

    Default job background
    Pharmaceutical / Bio-tech
    Description
    • Provide regulatory support to customers/ internal teams and assist in maintaining regulatory requirements at all levels
    • Coordinate for acquiring / renewal of FDA/FSSAI licenses, product approvals, chemist intimations/ approvals, maintain regulatory documentation and follow up on any Corrective action directed by the FDA officials
    • Coordinate with Global Regulatory Affairs (GRA) for support required regarding new regulations/ advisories, regulatory queries/ assessments/ documents, raw material information
    • Provide assistance to RA associates locally and at GRA
    • Work on local/ global projects assigned from time to time and meet deadlines
    • Assist in implementation of Regulatory strategy in line with Global and Local strategies as required.
    • Maintain Customer support system metrics, suggest improvements and coordinate with IT to resolve system issues
    • Track changes on regulations for Excipients and colors and provide update
    • Attend Global Regulatory Trainings and meetings – locally and overseas
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