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Assumes the responsibilities of the Regulatory Affairs Director during planned absences. This position reports to the Regulatory Affairs Director. The Regulatory Affairs Specialist is responsible for preparing Nutritional Facts and Ingredient Statements (reg sheets) for all products within the Bimbo Bakeries USA (BBU) organization, including private label brands and foodservice.
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As the newest Regulatory Affairs Manager, you will be responsible for registering current and newly acquired crop protection products in the U.S. and other regions (Asia/Pacific, Latin America, Africa, Europe, and Canada.
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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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This is what you will do:The Senior Director of Regulatory Affairs Chemistry, Manufacturing, and Controls (RCMC) will provide strategic as well as operational leadership of global CMC activities related to Cell & Gene Therapy (GCT) leading to successful registration and life-cycle management of unique and technologically complex products.
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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.
$117Full-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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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.
$117ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Reporting to: Senior Director, CMC Regulatory Affairs, The Manager/Sr. Manager, Technical Writing - CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs plays a critical role in ensuring compliance with regulatory requirements pertaining to drug development and manufacturing processes.
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The Associate Director of Regulatory Operations is responsible for the assembly, publishing, QC, submission, and archiving of regulatory filings to global Health Authorities (HA) in an efficient and timely manner.
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To do these effectively, the Analyst III – Policy & Regulatory Operations must have a demonstrated understanding of IEHP business operations and responsibilities of various departments in Health Services, Quality Systems, Provider Services, and Member Services; subject matter expertise of these departments’ policies and procedures and the regulations that drive their business operations and demonstrated ability to effectively and consistently manage multiple projects and priorities concurrently.
$80,059.2 - $106,059.2 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Tessenderlo Kerley, Inc. is adding an additional Regulatory Affairs Manager to join their talented Regulatory team. As a Regulatory Affairs Manager, you will interact with internal and external customers, including state/provincial and federal regulatory authorities, in support of NovaSource products.
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Advanced degree in Science, Healthcare, or Regulatory/Clinical Affairs. 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.
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Prior pharmaceutical industry experience and a minimum of 8 years in CMC Regulatory Affairs for Associate Director. Reporting directly to the Senior Director CMC of Regulatory Affairs, the (Associate) Director of Regulatory CMC will be responsible for the development of regulatory CMC submissions.
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Regulatory Affairs Chemistry, Manufacturing, And Controls (CMC) Internship Overview. Regulatory Affairs (RA) CMC develops and executes regulatory strategies in Chemistry, Manufacturing, and Controls (CMC) which use science to tell the story of our products in a clear and compelling way that leads to those products reaching patients quickly.
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This individual will build strong cross-functional relationships with Gilead’s Value and Access, Medical Affairs, Regulatory, Legal, and Public Affairs teams. Partner as appropriate with US Federal Government Affairs to align Gilead’s outreach with key US Government Agencies, such as the State Department, the Department of Health and Human Services Office of Global Affairs, the US Department of Commerce, USTR and relevant departments to support regional objectives.
$232,220 - $300,520ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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To foster a positive, creative, psychologically safe work environment within the US Pharmaceuticals team and the broader Global Regulatory Affairs organization. In collaboration with Regulatory Policy and Intelligence group, lead team to participate in industry associations to influence adoption of best practices in animal health regulatory advocacy programs critical to Elanco business success.
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Title: associate director regulatory affairs Company: Modalis Therapeutics
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