• Senior Director , Global…

    Lilly (Indianapolis, IN)
    …for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC ) leads and manages the scientific and ... regulatory efforts of the team, overseeing CMC regulatory activities for global submissions and...strategies for both development and commercial products. Additionally, the Senior Director is committed to fostering continuous… more
    Lilly (03/26/25)
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  • Associate Principal Scientist (Associate…

    Merck (North Wales, PA)
    …in pharmaceutical or combination product research, development and/or manufacturing + Experience with CMC regulatory where drug is the primary mode of action ... Description** This Associate Principal Scientist position is equivalent to an Associate Director position. Under direction from a Director , the Associate… more
    Merck (04/24/25)
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  • AD / Sr AD, US Product CMC

    Boehringer Ingelheim (Ridgefield, CT)
    …of increasing regulatory complexity and/or business impact. The Senior Associate Director , US Product CMC Regulatory Affairs is responsible for the ... and competitive advantage lie with our people. The Associate Director , US Product CMC Regulatory ...relevant topics. Additionally, with support and guidance from the Sr . Associate Director / Director ,… more
    Boehringer Ingelheim (03/04/25)
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  • Senior Director , Global…

    Takeda Pharmaceuticals (Lexington, MA)
    …as follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as ... guide the team to define and drive strategy for CMC regulatory dossier content and reviews this...timely manner. Acts as an advisor and liaison to senior management. + As a member of the modality… more
    Takeda Pharmaceuticals (04/30/25)
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  • Senior Director , Regulatory

    BeOne Medicines (Harrisburg, PA)
    …seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual leads biologics regulatory ... based in China and cross-functional stakeholders in developing and executing biologics regulatory CMC strategies, oversees CMC -related regulatory more
    BeOne Medicines (03/27/25)
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  • Associate Director , CMC Lead

    Daiichi Sankyo Inc. (Basking Ridge, NJ)
    …product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... within overall CMC development project(s), to support Sr CMC Lead. In case no ...- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or… more
    Daiichi Sankyo Inc. (04/21/25)
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  • Director of Drug Product Formulation…

    Boehringer Ingelheim (Ridgefield, CT)
    **Description** We are seeking a highly skilled and experienced Director to join our External Alternative CMC Development (EACD) team. The ideal candidate will ... external collaborations with Contract Development and Manufacturing Organizations (CDMOs). The Director will support all drug product-related CMC activities… more
    Boehringer Ingelheim (04/22/25)
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  • Regional Medical Director , CMC

    UTMB Health (Gatesville, TX)
    Regional Medical Director , CMC **Gatesville, Texas, United States** Physician UTMB Health Requisition # 2500313 The mission of Correctional Managed Care is to ... responsibility for all medical providers assigned within the region. Works under the director of the senior medical director . **_ESSENTIAL JOB FUNCTIONS_**… more
    UTMB Health (04/24/25)
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  • Sr . Director - Global…

    Lilly (Indianapolis, IN)
    …to make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) ... Industry-relatedexperiencein regulatoryaffairsand/ordrugdevelopmentexperiencefor 10years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable… more
    Lilly (04/05/25)
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  • Scientific Director / Sr

    Lilly (Indianapolis, IN)
    …global regulatory climate and emerging requirements; ability to address key CMC regulatory questions that enable clinical studies and support marketing ... concept) to product commercialization + Experience in development / CMC including quality and regulatory interactions is...in development / CMC including quality and regulatory interactions is expected + Experience with technical transfer… more
    Lilly (04/22/25)
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