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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.
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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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The Regulatory Specialist under the supervision of the Director of Accreditation and Regulatory Affairs has responsibility for site visit preparation, coordination of site visit logistics and response, as well as assist in preparing report-out to management of major regulatory changes and issues of mock or real survey results.
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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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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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Position Details Proposed Start Date 06/03/2024 Classification Title Administrative Support Rank N - No Rank Working Title Public Affairs Coordinator Department 100200 - GOV Government Relations Position Number D92013 Representation UU - Unclassified Unrepresented Renewable Renewable End date, if applicable Position FTE Tenure Status N - not applicable Position Summary Brief Description of PSU/School/Dept PSU is located in the Office of the President.
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The Health Affairs Institute serves as the coordinating office for WVU's State-University partnership with the WV DHHR. Ideal candidates will have work experience that aligns with the Health Affair's purpose and the mission of DHHR's Bureau for Medical Services, and an interest in improving the health of underserved populations, particularly rural, Appalachian populations.
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The Program Director reports to the Health Affairs Director of Program Development and Management and should be familiar with current/modern data-gathering techniques and technology, and have experience leading the work of large, federally sponsored program evaluation initiatives, such as those by the Centers for Disease Control and Prevention (CDC), Substance Abuse and Mental Health Services Administration (SAMHSA), or Centers for Medicare and Medicaid Services (CMS.
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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 29 days ago - UpvoteDownvoteShare Job
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This position will partner with Regulatory Affairs as the department brings publishing and submissions in-house. 7+ years of industry experience working in regulatory information management and submissions systems, Veeva RIM Vault experience highly preferred.
$126,500 - $160,100 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This position is a generalist position that handles matters in the areas of academic affairs, student affairs, administrative law, general risk management and insurance, policy review and legislation analysis, litigation support, ethics and conflicts of interest, HR/employment law, FLSA, FMLA, EEOC, information management, regulatory and compliance matters such as the Clery Act, FERPA, Title IX, Title VI, Title VII, and general higher education issues.
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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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Work within the student affairs and campus life response team protocols to provide crisis management support: assess severity of situation; consult with SSS staff and relevant offices (e.g., Health Services, Residential Life, Student Affairs, Counseling, Campus Police, etc.
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Student data Management - Working closely with the Associate Dean of AA, works collaboratively with admissions, academic and student affairs and institutional effectiveness to manage student data for all CAHS academic programs.
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Minimum of 8-10 years of relevant experience in government relations, legislative affairs, or related roles. Policy Advocacy: Monitor and analyze legislative and regulatory developments at the federal level.
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regulatory affairs jobs Title: regulatory affairs specialist Company: Sanofi
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