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The Executive Director, CMC Regulatory Affairs is responsible for developing and directing the regulatory CMC strategy, objectives, and programs pertaining to development and marketing of drug products.
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Interact with R&D, Marketing, Regulatory, Medical and Scientific Affairs, and other global functions as well as senior leadership teams and global partners to apply advanced critical thinking to build strategic plans for new biomarker development, stakeholder management, and technology dissemination such as Real-World Evidence, ensuring benefit from the new capabilities and opportunities these enable.
$185,500 - $235,500 a yearFull-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Advanced degree in Science, Healthcare, or Regulatory/Clinical Affairs. The Clinical Affairs Director for Beckman Coulter Diagnostics is responsible for leading comprehensive global clinical trial strategies to support the complex Clinical Chemistry and Immunoassay Biomarker-Flywheel (Biomarker) program and for managing a multi-level team of clinical managers and clinical scientists/affairs associates.
$185,500 - $235,500 a yearFull-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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You will be a part of the CCIA Clinical Affairs team and report to the Senior Director Clinical Affairs responsible for managing the CCIA portfolio for the Clinical Affairs department.
$185,500 - $235,500 a yearFull-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Clinical chemistry, immunoassay FDA & EU or Class III medical device experience with broad knowledge of medical device industry, regulatory requirements, and frameworks. This position is part of the Chemical Chemistry and Immunoassay (CCIA) Clinical Affairs department located in Chaska, Minnesota and can be remote.
$185,500 - $235,500 a yearFull-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Leverage Tesla's EHS management software to track: All regulatory reporting deadlines to assure deliverables are completed within required timeframes, including, but not limited to the following reports: biennial hazardous waste, Toxics Release Inventory, quarterly wastewater self-monitoring, greenhouse gas emissions, Emissions Inventory, and Title V annual and semi-annual.
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If so, this Director of Regulatory Affairs, Small Molecules CMC could be an exciting opportunity to explore. Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients.
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Responsible for precision medicine related review of medical and scientific content of Regulatory, Safety, Scientific Affairs, Medical Affairs and Commercial outputs for assigned therapeutic areas.
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Join us as a CMC Regulatory Affairs Specialist, where you’ll put your love of science to work in the Scientific Insourcing Services department. Review clients’ CMC program to identify critical gaps and provide regulatory strategy for the best path forward.
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Minimum 8-10 years of combined regulatory affairs experience in color cosmetics, both in domestic and international markets. Strong knowledge and expertise in international regulatory affairs and packaging/labeling compliance.
$130,000 - $150,000 a yearExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Effectively represent the Global Regulatory Affairs (GRA) function in senior-level interactions at internal governance technical review committees, key global health authority meetings, and external partners.
$165,200 - $236,000 a yearFull-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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The HEOR will report to the Executive Director of Medical Affairs Excellent interpersonal and communication skills will be necessary to support effective partnership with other key internal stakeholders from Clinical Science, Clinical Operations, Regulatory Affairs, New Product Development, and Marketing Demonstrated ability to effectively collaborate with external stakeholders including vendors and disease area/HEOR experts will also be required, with an EU and US focus.
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Provide regulatory guidance, general issue management and strategic stakeholder engagement support to Corporate Affairs and business leaders. Humana Director Public Policy, State Affairs Boise , Idaho Apply Now Become a part of our caring community and help us put health first.
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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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Humana Director Public Policy, State Affairs Tallahassee , Florida Apply Now Become a part of our caring community and help us put health first. The Director of State Public Policy role resides within the Corporate Affairs Department and will serve as an expert in state public payer, Medicaid and dual eligible public policy while working with subject matter experts and business units within the Humana enterprise including our Medicare, Medicaid, and CenterWell businesses.
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regulatory affairs jobs Title: sr director Company: Abbvie
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