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    • Regulatory Affairs Specialist for Labeling Operations - Mumbai - Apotex

    Apotex
    Apotex Mumbai

    1 month ago

    Default job background
    Description

    About Apotex Inc.

    We are a leading global health company that produces high-quality, affordable medicines for patients worldwide. Our team employs nearly 7,200 people across manufacturing, R&D, and commercial operations in over 75 countries.

    Job Summary:

    This role involves overseeing labeling updates and maintenance activities for New Product Development Label creation and Product Life Cycle maintenance in the Canadian market. You will interact with product contacts to address data-related queries or availability issues, coordinate with vendors/affiliates for timely artwork creation and updates, and collaborate with ARPL colleagues and Canada affiliates to address Health Authorities' requirements or queries.

    Key Responsibilities:

    • Coordinate and prepare regulatory submissions and strategies
    • Prepare and submit supporting documents for labelling submissions as per submission type for the Canadian market
    • Coordinate with POC/Vendor for Artwork creation and update
    • Maintain tracking requirements for Label update (RIMS, Tracking sheets, CCR, etc.)
    • Prepare and update labels/Monograph as per requirement in New Drug development or Product lifecycle maintenance in US and Canada market
    • Develop and maintain regulatory knowledge of Canada regulations
    • Manage final product submissions, negotiate, and communicate effectively with regional teams/regulatory authorities to obtain timely product approvals
    • Perform ESG submissions and maintain acknowledgments
    • Author responses and be a decision-maker for changes applicability in labels
    • Define priority of labelling requirements and plan submission based on priority
    • Maintain user-level knowledge of labelling software's
    • Interact with other internal departments when necessary
    • Show initiative to remain current on new labelling regulations and international guidelines and seek guidance from Leader and management to enhance knowledge
    • Perform all work in accordance with established regulatory and compliance and safety requirements
    • Work in a safe manner, collaborating as a team member to achieve all outcomes
    • Demonstrate behaviors that exhibit our organizational values: Collaboration, Courage, Perseverance, and Passion
    • Ensure personal adherence with all compliance programs, including Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies
    • All other relevant duties as assigned
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