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POSITION SUMMARY 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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In close partnership with Clinical R&D business process owners, sponsors & stakeholders including Clinical Science & Operations, Data Management & Biostatistics, Regulatory Affairs, PV, Biometrics, & Clinical Quality, provide leadership & subject matter expertise to drive timely & compliant planning, evaluation, procurement, implementation & operation of Clinical R&D systems.
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Cross-functional Collaboration: Collaborate with cross-functional teams, including clinical development, regulatory affairs, market access, and commercial teams, to align medical affairs activities with clinical trial objectives, regulatory submissions, market access strategies, and commercialization plans.
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We are hiring a Vice President of Regulatory Affairs to build our Regulatory function and define our global regulatory strategies from pre-IND to regulatory approvals across our in vivo and ex vivo gene editing product portfolio.
$305,000 - $365,000 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Reporting directly to the head of medical affairs, the Senior Director will play a pivotal role in leading the development and execution of strategies to generate and leverage real-world evidence to support the launch, development, market access, and commercialization of Aerovate's novel cardiopulmonary therapy.
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Our teams include Communications, Community Impact and Investment, Community Finance, CRA Strategy and Program Management, the Government and Political Affairs Group, Regulatory Relations, and Strategy and Engagement.
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Serve as the main administrative coordinator for the Office of Student Affairs events and work independently to oversee event logistics (including event planning, social media, event promotion, room set-up/clean-up, catering, AV, and IT) and coordinate with departments and offices on main campus and at the law school as needed.
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Strong knowledge of pharmacokinetics and modeling, pharmacodynamic principles, ADME concepts, bioanalytical principles, regulatory guidelines and clinical pharmacology requirements in late stage clinical development.
$220,000 - $240,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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In collaboration with Quality, Technical Operations, Regulatory Affairs, Clinical Operations, and Finance support automation (Veeva, SAP, logistics), document management (Veeva Vault, Veeva RIMS), and learning management (ComplianceWire) strategies for Kyverna’s operations including qualification, validation, and lifecycle management support.
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Our Regulatory Affairs team is seeking a highly motivated Regulatory Operations Manager. Reporting to the Senior Director of Regulatory Operations, you will be responsible for assembling, formatting, and publishing regulatory dossiers (e.g., IND, CTA, BLA, MAA) for global registration and lifecycle management submissions (e.g., supplements, amendments, variations) to meet corporate objectives for both ongoing business and new product development.
$130,000 - $155,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Provide current and consistent legal advice related to laws, regulations and industry trends affecting Vir and the biopharmaceutical sector, including, for example, healthcare laws, trade compliance guidance documents and regulations, healthcare regulatory issues, healthcare fraud and abuse, pharmacovigilance, advertising and labeling, product liability, pricing and reimbursement, antitrust, privacy, and other matters relevant to investigational and commercial therapeutic products.
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Collaborate with other Exelixis stakeholders (including Clinical Development, Clinical Operations, Data Management, Medical Affairs and Regulatory Affairs) to ensure appropriate collection and handling of safety data.
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More than 11,000 frail, elderly and disabled individuals receive in-home care, adult protection and support managing their affairs monthly and throughout the year, 16,000 seniors will receive services through the Area Agency on Aging.
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The Medical Science Liaison (MSL) is a member of a field-based team who function as an extension of the US Medical Affairs organization. MSLs provide medical information through scientific exchange in a fair- balanced manner and provide clinical/scientific support for Bristol Myers Squibb and the Medical Affairs department at the direction of Medical Affairs management.
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The NAGPRA Repatriation Team will report to the Chancellor's Designee, the Assistant Chancellor, Government and Community Relations in the Office of the Chancellor.
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regulatory affairs jobs Title: sr director Company: Csl Behring in Oakland, CA
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