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Dorsey is seeking a Regulatory Affairs Associate with four to six years of experience to join our Anchorage office. Among Dorsey’s many distinguished alumni are U.S. Supreme Court Justice Harry Blackmun, noted law professor and scholar William Prosser, Minnesota’s first woman judge Betty Washburn, former U.S. Vice President and Ambassador to Japan Walter Mondale, U.S. Senator Amy Klobuchar, former Corporation Counsel of the City of New York Zachary Carter, and U.S. Secretary of Agriculture Tom Vilsack.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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QUALIFICATIONS A scientific degree with directly relevant professional experience in small molecule development, global CMC regulatory affairs and CMC technical areas of at least 16 years with a BA/BS or 14 years with an MA/MS, PhD, PharmD, or MD. Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.
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The Regulatory Affairs Specialist is responsible for assisting the St. Croix Hospice Legal Department by filing, maintaining, and tracking government licenses and supporting documentation, responding to routine inquiries related to licensing, and supporting strategic growth efforts to obtain licenses.
ExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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With minimal oversight, the Pr. Regulatory Affairs Specialist (PRA) for the European Union Medical Device Regulation (MDR) will be responsible for supporting execution to MDR compliance plans to ensure all applicable technical files (for devices ranging from class I to class III) meet the EU MDR requirements on schedule.
ExpandApply NowActive JobUpdated 15 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.
$117ExpandUpdated 14 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.
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The VP, State Government & Regulatory Affairs is responsible for state governmental policy and advocacy matters, serving as Comcast's chief advocate on all public policy and regulatory matters before the Colorado State Legislature, Executive Branch, and the Public Utilities Commission.
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Manage accurate and timely safety related regulatory reporting (AEs, SAEs, UADEs) per study and regulatory requirements including collaboration with regulatory affairs and clinical operations, or overseeing activities of third-party managing safety reporting.
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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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This position requires excellent interpersonal and matrix leadership skills to support effective partnerships with key internal and external stakeholders including global/regional/local HEOR leaders, Department Heads, TA Heads, CMT Leads, Development, Regulatory Affairs, and Market Access.
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Works with Sr. Director, CA Chief Lobbyist Affairs and member companies to develop and execute lobbying strategies related to issues pending and anticipated before the legislature and relevant agencies.
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We invested in new offices, sector teams and practice groups including investor engagement; shareholder activism; governance; regulatory and public affairs, including geopolitical; crisis; litigation; social issues including climate change and diversity, equity and inclusion; cybersecurity, data and privacy; employee engagement; digital communications; opinion research and analysis, and; creative services.
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They facilitate effective communication and alignment between different departments to ensure product development goals, quality objectives, Scientific affairs, and regulatory compliance are met.
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Lead and work across a Cross Functional Matrix with both R&D internal partners including regulatory and scientific affairs, and functional, technical and commercial business leaders to create integrated plans and translate portfolio stewardship risks into transformation plans (including plans for risk mitigation of ingredients, creation of processing methods to address risks, to ensuring compliance and fit for purpose products in accordance with regulation.
$113,300 - $226,600 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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NVE, Inc. provides Program Management, Administrative Services, Engineering, Facilities Management, and Security services to a range of Federal and local agencies including the US Department of State, US Agency for International Development (USAID), Nuclear Regulatory Commission (NRC), US Army, General Services Administration (GSA), US Food and Drug Administration (FDA), US Geological Survey (USGS), Department of Commerce, and Virginia Railway Express (VRE.
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regulatory affairs jobs Title: intern Company: Nortonlifelock
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