• Associate Director , Global

    Takeda Pharmaceuticals (Bismarck, ND)
    …activities pertaining to global and local labeling compliance and quality within Global Regulatory Affairs . + Partners with internal stakeholders and ... to the best of my knowledge. **Job Description** The Regulatory Affairs -Labeling, Associate Director is...external CRO partners such as Global Regulatory Compliance, Global Labeling,… more
    Takeda Pharmaceuticals (11/27/24)
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  • Director Global Regulatory

    Takeda Pharmaceuticals (Bismarck, ND)
    …understands probabilities of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices… more
    Takeda Pharmaceuticals (12/06/24)
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  • Associate Director , Regulatory

    Sumitomo Pharma (Bismarck, ND)
    Regulatory Affairs ** . The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function ... registration strategy of a project in collaboration with the Global Regulatory Leader (GRL). He/she is expected...pharmaceutical industry with minimum of 6 years focused in Regulatory Affairs + Include the qualifications preferred… more
    Sumitomo Pharma (11/21/24)
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  • Director , Regulatory Affairs

    Sumitomo Pharma (Bismarck, ND)
    Regulatory Affairs ** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function ... as the Regional Regulatory Leader (RRL) and/or Global ...pharmaceutical industry with minimum of 8 years focused in regulatory affairs . + Master's degree required (preferably… more
    Sumitomo Pharma (11/28/24)
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  • Director , Medical Affairs Strategy…

    Sumitomo Pharma (Bismarck, ND)
    …website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. **Job Overview** The Director , Medical Affairs Strategy (Hematology/Oncology) will be a key ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...member of the Medical Affairs team reporting to the Executive Director ,… more
    Sumitomo Pharma (11/27/24)
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  • Senior Director , Medical Affairs

    Sumitomo Pharma (Bismarck, ND)
    Director , Medical Strategy (Rare Disease) will be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy. ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...and external facing HCP and Payer interactions. The Sr. Director of Medical Affairs develops and maintains… more
    Sumitomo Pharma (11/21/24)
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  • Director , Medical Affairs Strategy…

    Sumitomo Pharma (Bismarck, ND)
    …, Medical Strategy (Prostate Cancer)** will be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy. ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...and advance patient advocacy efforts to ensure that Medical Affairs activities align with patient focused programs. **Job Duties… more
    Sumitomo Pharma (12/05/24)
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  • Director , Field Medical and Scientific…

    Sumitomo Pharma (Bismarck, ND)
    …. **Job Overview** Director , Field Medical and ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...key insights obtained from the RDs to the Medical Affairs and other internal stakeholders in a timely manner.… more
    Sumitomo Pharma (12/14/24)
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  • Associate Director , Global

    Takeda Pharmaceuticals (Bismarck, ND)
    Regulatory Project Management and Strategic Planning - GI2 TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the ... implementing process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global more
    Takeda Pharmaceuticals (10/24/24)
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  • Executive Director , Device Quality…

    Merck (Bismarck, ND)
    …up with the latest regulatory guidelines and trends. + Collaborate with global regulatory teams to align strategies and ensure submission readiness in all ... **Job Description** The Executive Director , Device Quality & Regulatory will...emerging regulations and industry trends affecting device quality and regulatory affairs . Strategic Contributions + Serve as… more
    Merck (12/06/24)
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  • Associate Director , Global Labeling…

    Takeda Pharmaceuticals (Bismarck, ND)
    …+ Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned ... life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory more
    Takeda Pharmaceuticals (10/16/24)
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  • Associate Director , Global Patient…

    Takeda Pharmaceuticals (Bismarck, ND)
    …Liaise with and advise study teams including Clinical Science, Data Management, Regulatory Affairs , and other functional areas locally/globally on matters ... of clinical trial and Pharmacovigilance methodologies including detailed comprehension of global regulatory requirements. + Good cross-cultural understanding and… more
    Takeda Pharmaceuticals (12/06/24)
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  • Executive Director Head of Medical Strategy

    Sumitomo Pharma (Bismarck, ND)
    Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . **Job Overview** The **Executive Director Head of Medical Strategy** will be a key… more
    Sumitomo Pharma (12/05/24)
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  • Senior Manager, Biostatistics

    Edwards Lifesciences (Bismarck, ND)
    …and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more
    Edwards Lifesciences (10/28/24)
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