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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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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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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.
$117Full-timeExpandApply NowActive JobUpdated 11 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.
$117ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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CCRP - Cert Clin Research Prof (Preferred) or RAC - Regulatory Affairs Cert (Preferred) 2 Years experience in a regulatory role or 4 Years experience in related clinical research role (Required.
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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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PRIMARY RESPONSIBILITYThis role will lead the Regulatory Operations activities within Global Regulatory Affairs. This role is accountable for managing regulatory submission related activities, providing business ownership and management of IT systems within the scope of Regulatory Affairs, and supporting development of Regulatory Operations procedures and practices.
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Recruiter: Spencer Gregory Hale Regulatory Affairs Manager - Core CRM Sustaining Program Regulatory POC Team Purpose: The Rhythm Management (RM) Regulatory Affairs leadership team is a strategic partner that delivers innovative, efficient, and sustainable business and regulatory solutions for customers throughout the product lifecycle.
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Medical and Scientific Affairs serves a critical internal leadership and customer-facing support role, including pre- and post-market partnership to functions such as product management, sales and marketing, R&D, Clinical Affairs, Regulatory Affairs, Quality Assurance, Innovation, Strategy, Pharmaceutical Partnerships (Companion Diagnostics), and Technical Support.
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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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Fifteen (15) years of experience in Regulatory Affairs and Quality experience in the biotechnology, medical devices, or pharmaceutical industry with increasing responsibility (including interfacing with FDA and other regulatory agencies in development and commercialization of new medical technologies.
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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.
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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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A degree(s) in business, communications, marketing, public relations, government affairs, political science, technical area of specialty or relevant field may be substituted per LCRA guidelines for certain years of experience.
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10+ years experience in a relevant field, such as public policy or government relations, specifically in the area of regulatory affairs, public affairs, education policy, and advocacy.
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regulatory affairs jobs Title: compliance Company: Ey
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