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    Emerging Markets Regulatory Manager - Mumbai, India - Abbott Laboratories

    Abbott Laboratories
    Abbott Laboratories Mumbai, India

    Found in: beBee S2 IN - 5 days ago

    Default job background
    Full time
    Description

    Duties & Responsibilities

    Project Management:

    • Support Regulatory projects and Compliance standpoint on key projects within EM Regulatory groups
    • Management End to End key RA project: acting as project manager & connecting point among key EPD stakeholders within & out of Regulatory groups such as EM Commercial affiliates (Quality & Regulatory functions
    • Prepare powerpoints & Executive presentations for monthly reporting to Senior Leadership Team
    • Effective communication & interpersonal skills with the ability to collaborate with cross functional teams and convey compliance concepts to non technical stakeholders
    • Ability to work collaboratively within a team enviremnment, prioritize tasks & assist in managing multiple project simultaneoustly

    Data analytics:

    • Solid analytical skills with the ability to comprehend & apply regulatory requirements to operational processes
    • Perform extensive data analysis, generates weekly, monthly reports & trends
    • Preparing RA reports for all regulatory activities (New registrations, renewals, LCM)
    • Monitor timely RA submission & approvals & report all the significant events& changes in the regulatory environment

    Maintain an up-to-date database for all submissions

    Compliance:

    • Issuing and updating the SOP in line with Global SOP and Local Regulation in EM countries.
    • Guarantee the compliance with national legislation, international regulatory guidelines and internal requirements.
    • Ensure that the End to End compliance management process is in compliance with the local regulation and global SOP..
    • Support / execute Audit preparation, Non conformance report and validation CAPA plans
    • Assure Record Management plan for all Regulatory documentation
    • Proven track record of developing 7 implementing compliance program procedures
    • In depth knowledge of regulatory requirements

    Experience Required

    • Education: Chemistry, Pharmacy.
    • Years of Experience: at least 7 years in Regulatory Affairs & RA compliance, data analysis, project Management ...
    • Language: Fluent English
    • Location:India Mumbai
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