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    Executive or Sr. Executive Regulatory Affairs Brazil - Mumbai, India - Unichem Laboratories Limited

    Unichem Laboratories Limited
    Unichem Laboratories Limited Mumbai, India

    1 week ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Qualifications: B.Pharm/ M. Pharm/ M.Sc.

    Location: For two years in Brazil Office followed by Office in Mumbai

    Job description

    Responsibilities

    • Ensure change management, post approval changes to ANVISA
    • Review of technical documents for new submissions, post approval changes (Individual Protocol, HMP).
    • Writing PATE for post approval changes
    • Respond to technical deficiencies received from ANVISA
    • Maintain department records as assigned.
    • Application for Good Manufacturing Practices to ANVISA
    • Coordination of Pharmaceutical and Analytical Testing laboratory and Clinical Research Organization for PE and BE studies.
    • Coordination with ANVISA for technical queries

    Desired Skills

    • Complete knowledge of ANVISA regulatory guidance
    • Proficient in new product submissions for solid oral dosages, parental/sterile formulations to ANVISA
    • Reading/Writing Portugal language preferred or willing to learn the language.
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