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Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in Research and Development, Regulatory Affairs, and Clinical Development.
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This full-time position, based in Kingsport (other regions or home office can be considered), will be part of the corporate Product Stewardship and Regulatory Affairs (PSRA) organization.
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Reports to: Global Regulatory Affairs Director. This Senior Regulatory Affairs Specialist will have an opportunity to work on new to market technology that is improving the field of diagnostic imaging and saving patient lives.
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Counsel and advise the BU in areas of product safety (including TSCA, FIFRA, FDA, OSHA Hazard Communication, Hazardous Materials Transportation), product regulatory affairs, product stewardship, and product risk management as such areas may impact the research, development, manufacture, marketing, sale, handling, transportation and advertising of the BU(s) products.
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Leads the execution of global CMC regulatory plans, including overseeing the submission preparation process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.
$237,660 - $307,560Full-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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The Director of Federal Government Affairs represents the organization's policy and regulatory positions to elected representatives and their staff, as well as to officials and staff in the executive branch and other agencies.
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Posted Job Title Director of Regulatory Affairs, Academic Affairs Office, Penn Law Job Profile Title Director B Job Description Summary The University of Pennsylvania Carey Law School is one of the nation's oldest and most distinguished law schools.
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The Director, Regulatory Affairs at CPS, Inc. will serve as the leading expert in Scientific & Regulatory Affairs, overseeing all facets of U.S. and international regulations (EU, CAN, AUS, and others), alongside the management of 3 rd party certifications for our entire product portfolio.
$165,000 - $180,000ExpandApply NowActive JobUpdated 27 days ago - UpvoteDownvoteShare Job
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Under the supervision of the Regulatory Program Manager of the Regulatory Review Unit, the Assistant Regulatory Affairs Coordinator (ARAC) supports the clinical research efforts of the Cancer Center by providing comprehensive, regulatory management of cancer-related protocols in accordance with human subject federal regulations, internal standard operating procedures (SOPs), and University policies and procedures.
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Communicate regularly and effectively in a cross-functional matrix with development, origination, fundamentals, finance, and political & regulatory affairs staff to translate regulatory and market issues into business impacts and opportunities to benefit the position of Pattern's new and core business interests in MISO and other priority markets.
$103,000 - $139,000ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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East West Tea is seeking a talented, passionate, and experienced Principal Scientist to join our Quality Assurance team to play a pivotal role in shaping the future of Yogi, leading Regulatory Affairs, to ensure compliance and management of legal risk.
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Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams. Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions.
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We are seeking an innovative and highly motivated Principal Scientist, Scientific Affairs who will contribute significantly to the development and continued growth of our advanced cell therapy manufacturing platform.
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Description As a Director, Global Regulatory Affairs, Precision Medicine you will develop and execute Precision Medicine regulatory strategies in alignment with the drug global regulatory strategy in collaboration with cross functional stakeholders across the Gilead therapeutic areas and in compliance with the appropriate regulations.
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We are seeking a driven, creative, collaborative, and highly respected individual who is passionate about public policy, government affairs, regulatory policy, helping patients, innovative science, biotechnology, and public health to serve as Vice President, Policy & Advocacy.
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regulatory affairs jobs Title: clinical director Company: Global Life Science Hub in East-hartford, Connecticut
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