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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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Mammoth is hiring a Director/Sr. Director, Regulatory Affairs, Therapeutics, to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market.
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Provide legal advice and support for our U.S. businesses and Environmental, Health, & Safety team covering a broad range of environmental, safety, and regulatory issues. 5 to 15 years practicing law with experience in environmental or regulatory work (5 years of law firm/private practice experience preferred.
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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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Medical Affairs: TA Heads, Executive Directors, CMT leads, ESMA leads, Senior Medical Directors/CMT members, HEOR Leaders. Provide oversight and strategic and scientific input for HEOR projects, data interpretation, protocol development, regulatory documents, scientific publications, and independent research proposals for assigned products.
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The Manager of Quality Assurance and Regulatory Affairs, Laboratory Services provides CLIA compliance in a clinical lab setting supporting clinical testing services and projects. 5-7 years of quality assurance or regulatory certification experience in a CLIA and/or GCP / GLP laboratory environment.
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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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Develops, updates and maintains installation EFMP education, outreach and public affairs programs, to include awareness briefings for command, unit, community organizations, individuals and families and distinguished visitors.
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Key ResponsibilitiesStrategy and Execution:Uses an understanding of disease biology, the drug development process (particularly cross-functional connectivity), and relevant late-stage challenges (e.g., trends in disease area therapeutic advances, and evolving regulatory, patient advocacy and market access environments) to create a vision for each asset, then design and execute effective development programs in support of the overall R&D portfolio goals.
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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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Support Danaher Diagnostic Operating Company Medical and Scientific Affairs and Government Affairs organizations on their strategy so that it maximizes patient impact at scale. Prior roles in industry Medical and Scientific Affairs and/or Government Affairs functions a plus.
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The Director of Quality & Regulatory reports directly to the VP, Medical Affairs. Review audits and ongoing monitoring of DEA compliance, FDA compliance, PDMP compliance, OSHA compliance, HIPAA and HITECH compliance, and Boards of Pharmacy regulatory compliance, and compliance with client KPIs. Partner with the CCO to the design and maintenance of quality programs, including but not limited to QA plans, inspection procedures, work instructions, training, deviation investigations and CAPA management, facility mapping and validation projects.
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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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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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regulatory affairs jobs Title: intern Company: Rockland Trust
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