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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. Senior Regulatory Affairs Specialist-Remote Based-West Coast.
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The Analyst II, Regulatory Affairs has experience with and performs key centralized complex and difficult regulatory activities for the Compliance Department. Knowledge of and experience with state and Federal regulatory and other requirements and practices related to Covered California, Medicare and Medi-Cal (Medicaid), Title 19 (USC)/Title 29 (USC and CCR), Title 22 (CCR), Title 28 (CCR), Title 42 (USC and CFR), CA Welfare and Institutions Code, and CA Health and Safety Code.
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The Associate Director, Regulatory Affairs will establish and grow internal CMC regulatory activities, providing strategic management and content plans to support Vyriads gene therapy product development, registration, and post-approval strategies.
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Job DetailsThe Director of Risk Management and Regulatory Affairs (Patient Safety Officer/Privacy Officer) serves as an accessible resource to the hospital and community on risk management and regulatory issues.
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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 22 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 22 days ago - UpvoteDownvoteShare Job
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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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As a key member of our legal department, the Senior Manager of Regulatory Affairs/In-House Counsel will play a crucial role in managing regulatory compliance, with a primary focus on collections and litigation.
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The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials under INDs/CTAs and transition to appropriate GMP validation to move expeditiously in Phase 3 trials with material suitable for commercialization to support market access for Voyager's gene therapy products.
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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 22 days ago - UpvoteDownvoteShare Job
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Accountable for planning, design, execution, and results of the Clinical Affairs Biomarker team & clinical trials program. If you thrive in a an amazing, multifunctional, fast paced role and want to work to build a world-class clinical affairs organization—read on.
$185,500 - $235,500 a yearFull-timeExpandApply NowActive JobUpdated 24 days ago - UpvoteDownvoteShare Job
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Providing overall leadership and direction to the Quality Assurance and Regulatory Affairs McKesson 3PL Team. The Senior Director, QARA is principally responsible for the development and implementation of the Companys quality assurance program through the development and implementation of quality assurance and compliance standards via policies and procedures, training, auditing and monitoring, facilitating internal reporting, compliance-related investigations, and keeping Third Party Logistics VP of Quality Assurance & Regulatory Affairs informed on quality assurance and regulatory affairs matters.
$142,200 - $237,000 a yearExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Responding promptly on detected offenses, developing corrective action, and reporting findings to the VP, Quality and Regulatory Affairs. The Senior Director, Quality Assurance and Regulatory Affairs (QARA) collaborates to set policy and procedures and then audits/monitors quality assurance.
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Comprehensive knowledge of FDA & EU IVD regulations experience including a conversant knowledge of evolving China regulatory expectations. 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 24 days ago - UpvoteDownvoteShare Job
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Software company is seeking a detail-oriented and highly organized Senior Manager of Regulatory Affairs/In-House Counsel to join our team. Job Title: Sr. Manager of Regulatory Affairs/ In-House Counsel at Software Company.
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regulatory affairs jobs Title: regulatory affairs specialist Company: Jazz Pharma
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