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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.
$165,200 - $333,800 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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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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Capability in managing deliverables essential for regulatory permit applications, CEQA documents, and environmental due diligence investigations (e.g., wetland delineations, rare plant surveys, habitat assessments, biological resources technical reports.
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Lead regulatory risk assessment, identify key CMC regulatory issues and mitigation activities needed throughout product life cycle. Provide CMC regulatory review for clinical protocols and investigator brochures, etc.
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At Mercury regulatory compliance is not just a necessity but a competitive advantage that can set us apart as the leader in the space. Your team will manage all of our existing and future regulatory relationships, helping to establish Mercury’s reputation as an effective steward of the financial system.
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In this role you will join a team of program managers, uphold and maintain the Cash App product's licensing and regulatory obligations, and manage projects and strategic initiatives concerning parties external to Cash App, such as regulators, partners, and consultants.
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Develop and lead CMC Regulatory strategies for a portfolio of programs in development, including AAV gene therapies and small molecule drugs. Align CMC regulatory strategy to overall regulatory business strategy (e.g. viral vector upcoming process, raw material, shelf-life and analytical changes.
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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.
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As a senior member of the Compliance team, you will be responsible for establishing a vision for regulatory compliance at Mercury, developing team and cross-functional strategy along the way and implementing the right governance mechanisms to ensure a robust and resilient program.
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The Regulatory Coordinator must demonstrate exacting knowledge and compliance with UCSF policies, TRACK-TBI NET policies, ICH GCP, SOPs, regulatory agency policies, and documentation requirements, along with other applicable policies of funders and collaborators.
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The ideal candidate must possess strong accounting, compliance, regulatory reporting and operational expertise, an ability to communicate and work with various teams outside of Finance (such as Legal/Compliance, Trading Operations and other Product/Engineering groups), and a desire to make a significant impact on a dynamic, high-growth technology company.
$161,500 - $190,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The Regulatory Coordinator will provide support within the Administrative Core as the coordinating center for Transforming Research and Clinical Knowledge (TRACK) in Trauma Brain Injury Network (TRACK-TBI NET) a research consortium composed of 18+ US Level 1 Trauma centers that conduct TBI clinical research both under independent and federal regulatory supervision.
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Travel may be required Certification in regulatory affairs, quality assurance or clinical research; ASQ (American Society for Quality) Certification is preferred. Lead change management across study teams in support of increased regulatory management; establish faculty relationships and channels of communications to keep faculty apprised of central regulatory operations.
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This is a full-time role that can be remote and will report to Cash App's Lead Payments Regulatory Counsel. Job Description Cash Apps dedicated Legal Team is looking for a Payments Regulatory Counsel to provide strategic counsel and support to our business and compliance partners.
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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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Title: regulatory Company: Clarivate Plc in Oakland, CA
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