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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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This Senior Regulatory Affairs Specialist will have an opportunity to work on new to market technology that is improving the field of diagnostic imaging and saving patient lives. Senior Regulatory Affairs Specialist-Remote Based-West Coast.
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Allogene is seeking a Senior Director, CMC Regulatory Affairs to provide support for products under development and lead CMC product strategy and provide regulatory direction to quality, manufacturing/tech ops and supply chain teams.
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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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Manage regulatory affairs and ensure regulatory compliance of studies, including Institutional Review Board (IRB), National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), Data Safety Monitoring Board, Food and Drug Administration (FDA), and/or other funding or regulatory agency reports.
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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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Job Overview: A law firm in San Francisco, CA, is seeking a Mid-Level Environmental Associate Attorney with significant expertise in environmental law, encompassing regulatory counseling and litigation.
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5+ years of experience as in-house counsel advising product teams and/or leading regulatory coverage preferably in fintech or institutional financial services. You will partner with innovative product teams harnessing the power of crypto assets and blockchain technology to develop the new financial account for businesses and help plan and implement regulatory strategy against the evolving regulatory landscape for stablecoins and other digital assets.
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The AD/Director, Commercial Financial Planning & Analysis (FP&A) will support BeiGene, Ltd.s U.S. and Canadian businesses, covering Commercial and Medical Affairs. Lead financial planning & analysis (Long Range Planning, Annual Operating Plan, Quarterly Forecasting), and management reporting for US and Canada Commercial & Medical Affairs.
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You will be a trusted advisor to senior management and provide guidance on a spectrum of regulatory matters at the enterprise level across all of our business units: Square, Cash App, TIDAL, TBD, Proto and Spiral.
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Health care regulatory knowledge focusing on Fraud, Waste, and Abuse; knowledge of Value-based care, Medicare Advantage Organizations, ACO REACH and MSSP programs is required. This role will provide regulatory guidance on various healthcare-related issues with a focus on Anti-kickback Statute (and related state statutes), Stark Law, Civil Monetary Penalties Law, and develop compliant solutions to to facilitate and promote One Medicals business objectives, including value-based care, care coordination, and clinical integration.
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The executive vice chancellor area also includes the Divisions of Undergraduate Education, Graduate Education and Postdoctoral Affairs, Enrollment Management, several academic support units, as well as units under the purview of the Vice Chancellors for Student Affairs and Equity, Diversity & Inclusion.
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Works collaboratively with vendors, Clinical Research, Drug Safety, Regulatory Affairs, Clinical Operation, and Project Management teams to meet project deliverables and timelines for statistical data analysis and reporting.
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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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Lead and develop a team of regulatory affairs professionals in areas such as HazCom management, product stewardship, new product development support, labeling reviews, and lifecycle support activities.
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regulatory affairs jobs Title: sr affairs associate in San Francisco, CA
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