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Dorsey is seeking a Regulatory Affairs Associate with four to six years of experience to join our Anchorage office. This associate will have the opportunity to work on a wide variety of issues and matters, including corporate and municipal governance, contracting, financings, real property, proxy and proxy statements, and annual meetings (parliamentarian and inspector of elections), in addition to commercial telecommunications and merger and acquisitions.
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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.
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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.
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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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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.
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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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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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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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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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As The Focus Of This Internship, We Would Like To Study The Potential For How Generative AI Can Be Used In The Drug Development Lifecycle To Accelerate The Approach To Areas Such As Regulatory Filings, Generation Of Real World Evidence, Clinical Trial Documentation And Audits.
$10,120 - $12,170 a yearInternExpandApply 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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Reporting to the Managing Counsel, Health Affairs, Privacy & Data Protection Law, the Principal Counsel - Health Regulatory provides primary legal support to the University's medical centers and health sciences schools on complex and high impact healthcare regulatory analysis.
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Author product statements and documentation in compliance with international and country specific legislation (e.g. product dossiers, registration certificates) with the support of the SDS authoring specialist for label data, GHS classifications, Dangerous Goods classifications, worker safety or environmental risk assessments and with the support of the Regulatory affairs team for site specifics and environmental regulation.
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regulatory affairs jobs Title: sr regulatory affairs associate Company: Cardinal Health
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