• Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... areas centered around rare diseases and immune disorders. Summary The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides planning and… more
    HireLifeScience (03/26/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... diseases and immune disorders.Summary The Director, Head of Global Dossier Planning, Regulatory Operations is responsible for leading the dossier planning team and… more
    HireLifeScience (03/25/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… more
    HireLifeScience (03/19/24)
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  • Eisai, Inc (Nutley, NJ)
    At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... strategies and business solutions for the development and maintenance of Eisai regulatory systems. Establish, manage, and support regulatory systems according to… more
    HireLifeScience (03/08/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    … Writing function, overseeing, directing and being accountable for all regulatory / medical writing strategy and activities for Daiichi Sankyo's portfolio, ... is the single-point of accountability to set global standards for regulatory / medical writing related activities, processes, innovations and improvements, and… more
    HireLifeScience (03/01/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic… more
    HireLifeScience (03/01/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… more
    HireLifeScience (03/03/24)
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  • Merck & Co. (North Wales, PA)
    …review and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that ... promotional practices are consistent with regulatory guidelines, our company's policies, and support business objectives.Serve as the liaison and manages… more
    HireLifeScience (03/01/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... and immune disorders. Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's … more
    HireLifeScience (03/01/24)
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  • Merck & Co. (North Wales, PA)
    …intellectually curious, join us-and start making your impact today.-Overview: The Regulatory Digital Health (RDH) department engages with enterprise leaders across ... to support OPS (Operations, Processes, and Strategic Execution) Policy Execution and the regulatory strategy of digital health tools (DHTs) and software medical more
    HireLifeScience (02/28/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... This role is responsible for leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through direct and indirect line management, to… more
    HireLifeScience (02/23/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …veterans and people with disabilities.SummaryThis position leads the Global Regulatory Affairs (GRA) Global Labeling function, combining knowledge of scientific, ... regulatory , and business perspectives to ensure compliance with evolving...regional leaders from Supply Chain, Clinical Safety Pharmacovigilance, Commercial, Medical Affairs and Legal) to ensure accurate and high-quality… more
    HireLifeScience (02/23/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
    HireLifeScience (02/23/24)
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  • Astellas (Westborough, MA)
    …drives our strategic thinking and day-to-day decision-making. We focus on addressing unmet medical needs and conduct our business with ethics and integrity, so that ... II, Analytical Development Senior Project Manager, Technical Operations Senior CMC Regulatory Affairs Manager, Cell/Gene Therapy Manager CMC Regulatory Affairs,… more
    HireLifeScience (01/14/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …issues for assigned products; provides content guidance and functional approval for regulatory responses for other Medical Safety Leads.Maintain and evaluate ... Executive Director (ED) will provide leadership to the DSPV Medical Safety Team. He/She will be accountable for the...time and in accordance with all relevant company and regulatory policies and procedures. In addition, the ED will… more
    HireLifeScience (03/12/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
    HireLifeScience (03/15/24)
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  • Novo Nordisk Inc. (Atlanta, GA)
    About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
    HireLifeScience (03/23/24)
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  • Merck & Co. (North Wales, PA)
    …Description: Essential functions include, but are not limited to:Performs primary medical review-of serious adverse experience reports and other AE reports of ... team to:- prepare responses to inquiries from health professionals and regulatory agencies regarding adverse experiences reported for company products; strategizes… more
    HireLifeScience (03/23/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …available clinical data and promotional content within the assigned therapeutic area. Regulatory milestones, actions and guidance relevant to medical review ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
    HireLifeScience (03/20/24)
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  • George Washington University (Rockville, MD)
    …The Biostatistics Center is a leader in the statistical coordination of major medical research programs of national and international scope. Visit our website at: ... include:-Designs and leads the development of the EHR infrastructure to meet regulatory and privacy compliance and develop interfaces between EHR systems and BSC… more
    JobGet (03/01/24)
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