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    Strategist, Global Regulatory Affairs CMC, Associate Director - Boise, United States - Idaho State Job Bank

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    Strategist, Global Regulatory Affairs CMC, Associate Director at Takeda Pharmaceuticals in Boise, Idaho, United States Job Description By clicking the 'Apply' button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use .

    I further attest that all information I submit in my employment application is true to the best of my knowledge.

    Job Description We are seeking a highly motivated and qualified regulatory CMC professional for the Global Regulatory Affairs CMC & Device organization in the Plasma-Derived Therapies Business Unit at Takeda.

    The Global Regulatory Affairs CMC & Device organization is responsible for global CMC regulatory strategies and activities for the PDT BU product portfolio through clinical development, market launch and product lifecycle management.

    The Strategist works in a highly highly matrixed, global product team-oriented environment and ensures close collaboration within the Global Regulatory Affairs CMC & Device organization and with other PDT BU functions and relevant Takeda R&D functions to provide an effective and aligned regulatory CMC strategy and submission approach globally, regionally and locally.

    ACCOUNTABILITIES The Strategist, Global Regulatory Affairs CMC, PDT BU is responsible and accountable for:
    + Defining, coordinating and implementing global CMC regulatory strategies for product-specific development and life-cycle activities + Providing proactive strategic guidance to the product-specific global regulatory and manufacturing sub-teams for defining global regulatory CMC strategies and objectives pertaining to the development, registration, commercialization and lifecycle management of the drug product in the United States and international markets. + The role liaises directly with the US FDA and with local regulatory teams for discussons with international health authorities and agencies for CMC-related matters. Negotiates with regulatory authorities during the development process to ensure submission acceptance and approval. + Manages the CMC regulatory strategy of high quality and compliant regulatory CMC documentation (e.g., BLAs, INDs, CTAs, MAAs, Variations/Supplements and other relevant regulatory filings such as meeting requests and briefing packages) for the assigned product(s) within defined timelines as per R&D and business objectives. + Advises on regulatory strategies, solutions to scientific problems and interpretation of results in the context of product registrat To view full details and how to apply, please login or create a Job Seeker account

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