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Under the supervision of the Regulatory Program Manager (RPM) of the Regulatory Affairs Unit, the Regulatory Affairs Coordinator (RAC) supports the clinical research efforts of the Chao Family Comprehensive 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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The incumbent is also responsible for maintaining communication with all elements of a multi-level research network, including attending Disease Oriented Teams (DOTs) meetings, interacting with sponsoring agencies including National Cancer Institute, and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors.
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The Associate, Regulatory Affairs will be a critical team member supporting regulatory strategy and submissions for the firm’s Neuro, Digital Health, and AI/Imaging clientele. 1-3 years of experience in regulatory affairs related to medical devices, drugs and/or biologics, assisting in the writing and/or reviewing of regulatory submissions.
$50,000 - $70,000 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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BryceTech is looking for an experienced Regulatory Affairs Analyst to support the DHS FEMA, Office of Response and Recovery, CBRN program, supporting the Office of Emerging Threats Professional and Technical Services Contract.
$95,000 - $105,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Associate Director, CMC Regulatory Affairs page is loaded. Associate Director, CMC Regulatory Affairs. The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions.
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15+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs/small molecules.
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Juris Doctor degree from an accredited school of law, admission to the New York State Bar (NYS Bar), and five(5) years of responsible experience in the practice of law following NYS Bar admission, in the fields of health care compliance, regulatory affairs, risk and quality management and/or in similar areas; or.
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You have experience with US regulatory affairs submissions such as 510(k) and/or PMA. You have at least 10 years of experience in this field so far in your career. You are a seasoned professional in the Regulatory Affairs space with specific experience with IVD and POC products.
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This role will report to the head of Global Regulatory Affairs and is responsible for overseeing and directing all CMC regulatory support and submissions for late-stage development and commercial products.
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Minimum 5 years in Regulatory Affairs within any of the following industries: pet food, food, OTC drugs, medical devices or pharmaceuticals; Create and foster a climate of teamwork and effective working relationships both within Regulatory Affairs and with our internal business partners: Quality, Marketing, Legal, New Product Innovation, Science & Technology, Professional Veterinary Affairs, Supply Chain, and others to achieve the synergy needed to effectively work as a team and promote the business.
$128,000 - $150,000 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Blackrock Neurotech, a leader in neurotechnology, is seeking an experienced and visionary Head of Regulatory Affairs to design and execute global regulatory strategies for our Brain-Computer Interface (BCI) platform technology and its applications.
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Interface effectively with all other BMS internal stakeholders: Global Medical Affairs functions and other departments, including Commercial, Clinical Research and Development, Regulatory Affairs, Managed Care, Pharmacovigilance, Market Access, Statistics, Translational Research/Development, Project Leadership, etc.
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Piper Companies is currently seeking a Regulatory Affairs Specialist, Gene & Gene Therapy for an opportunity in Philadelphia, Pennsylvania (PA), to join an innovative biotechnology company creating life-saving cell therapies.
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CMC Regulatory Affairs, oncology, small molecule, drug development, clinical development. Director, CMC Regulatory Affairs. Serve as the PDM regulatory representative on project teams, provide CMC regulatory support for the clinical development of the investigational product(s), and ensure applicable regulatory requirements are appropriately met.
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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. Candidate must have 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.
$71,572.8 - $93,038 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago
regulatory affairs jobs Title: affairs Company: Jobget
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