Senior Regulatory Affairs Specialist - Schaumburg, IL - Staffing Network LLC

    Staffing Network LLC
    Staffing Network LLC Schaumburg, IL

    6 days ago

    $95,000 - $150,000 (USD) per year *
    Description

    Senior Regulatory Affairs Specialist

    This individual will establish regulatory affairs business processes to ensure compliance with all relevant governmental regulatory authorities, focusing on the US FDA and Japanese regulatory bodies. Supported products include IV solutions, drug products under CFR 210 and 211, biologicals, APIs, combination products and medical devices.



    Key Responsibilities:

    • Serve as primary communication contact for US FDA (CDER, CDRH, CBER etc.)
    • Translate and review package inserts and interview forms in English
    • Maintain up-to-date knowledge of changes to the regulatory environment in key markets and communicate impactful developments to affected departments

    * This salary range is an estimation made by beBee
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    Regulatory Affairs Specialist

    Only for registered members

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    Senior Regulatory Affairs Specialist

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    Senior Regulatory Affairs Specialist

    Staffing Network LLC

    Job Overview/Objectives: · This individual will establish regulatory affairs business processes to ensure compliance with all relevant governmental regulatory authorities, with a near term emphasis on US FDA and Japanese regulatory authorities. The categories of supported product ...

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