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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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Manages responses to requests involving Securities and Exchange Commission (SEC) oversight inspections and examinations, which includes the identification and collection of responsive documents, conducting due diligence reviews on proposed responses, drafting response letters, obtaining necessary supervisory approvals, and coordinating with other Regulatory Operations (RegOps) groups and FINRA’s Office of Oversight Liaison and Counsel (OLC) to make timely and accurate productions.
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Performs testing as required for research, new product/process development projects, or process improvements in compliance with LifeNet Health (LNH) Quality Systems (QS)/Regulatory Affairs (RA) standards and organization procedures.
$64,679 - $86,238 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The Senior Advisor/Director in Global Regulatory Affairs – CMC will leverage CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for clinical trials and marketing authorizations for the synthetic molecule portfolio, including small molecules, peptides, and oligonucleotides.
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Support project team lead to author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. Excellent technical writing skills with attention to detail in authoring methods, specifications, technical reports, and regulatory filing documents.
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Support regulatory filings by guiding the draft, review, and approval of CMC sections; support associated agency interactions and product-related inspections Partner with cross functional members across Gilead Pharmaceutical Development & Manufacturing (PDM), including Quality, Supply Chain, Manufacturing, Regulatory Affairs CMC, Finance and Technical Development to ensure successful commercialization of the late-stage portfolio, as well as on time delivery of clinical and commercial product.
$274,635 - $355,410 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Business Affairs consists of 5 divisions reporting to the Associate Vice President for Business Affairs/Controller and provides direct services to staff, students, and UO departments: Financial Services/Accounts Payable/Travel, Student Financial Services, Payroll, BA Information Systems, and Treasury Operations.
$35.81 - $56.79 an hourFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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The Kellogg Institute for International Studies , part of the Keough School of Global Affairs at the University of Notre Dame, is seeking two postdoctoral researchers as part of the universitys Democracy Initiative for the academic year 2024-2025.
$56,484 - $63,852Full-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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ARM will also be required to coordinate and communicate cross-functionally within NPC (e.g., Patient Support Center, Customer Engagement, Marketing, Market Access, Public Affairs, State & Government Affairs, Trade, Specialty Pharmacy Account Management, and other applicable third-party affiliates.
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Access & Reimbursement Manager, CV is a remote/field-based role that covers the following states but not limited to Augusta GA, Athens GA, Gainesville GA, Lawrenceville GA, Rome GA. Candidate must reside within territory, or within a reasonable daily commuting distance of 60 miles from territory border.
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As Lead Biostatistician, you will leverage your knowledge and experience in applying advanced statistical methods and SAS skills to lead or help drive one or more Phase I-IV trials, with a focus on any of the following: Immunology, Early Development, Medical Affairs, Oncology, and Infectious Disease studies.
ExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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GPS also administers the International Studies Program, a fast-growing interdisciplinary program with over 1700 declared undergraduate majors, that offers a rigorous curriculum for undergraduate students interested in international affairs.
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Experience in health education, health promotion, student affairs, or higher education administration. The University at Albany is hiring an Assistant Director: Health Education within the new Office of Health Promotion, which is part of the Well-Being Cluster of Student Affairs.
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Position Overview: The Associate/Manager – CMC Regulatory is responsible for the preparation and delivery of high-quality CMC regulatory submissions. Responsibilities: Responsible for the generation and execution of country specific CMC regulatory strategies Author and review global CMC dossiers Coordinate and contribute to responses to regulatory agency questions Participate as an active member of cross-functional teams and ensure alignment of global regulatory strategies with CMC development and commercial plans Maintain submission information according to the Regulatory Information Management (RIM) system.
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Responsibilities Primary, direct legal counsel supporting activities related to one or more specific product franchises for the commercial, medical affairs, regulatory, and corporate communications functions.
Full-timeExpandApply NowActive JobUpdated 2 months ago
regulatory affairs jobs Title: regulatory affairs project manager Company: Amgen
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