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This role requires the incumbent to also provide administrative, regulatory and policy support across all functional units within the Office of Ethics & Compliance (OEC), as needed. The Senior Ethics & Compliance Specialist/Regulatory Support Manager is a subject matter expert on FDA regulations, the university’s policies, processes, and standards.
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In addition, the applicant is expected to develop a strong research program, funded by federal and other grants, broadly in the areas of drug development, computational drug discovery and development, or regulatory science.
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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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We are looking for a Regulatory Lead to drive the development and execution of Cash App’s anti-money laundering and regulatory program strategy. The Regulatory Lead will report to the Head of Strategy for Cash App Compliance and work internally alongside Compliance partners including Global Policy & Governance, Product Risk & Compliance, and Cash App Program Management.
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Experience in filing regulatory submissions from early development to pre and post approval submissions and product lifecycle management in the area of Cell Therapy. Maintain detailed knowledge of global regulatory environment relevant for cell therapies and regenerative medicine including accelerated review programs.
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Compliance and Regulatory Oversight: Ensure compliance with relevant laws, regulations, and standards (e.g., GDPR, CCPA, SOX, PCI-DSS). Demonstrated experience in risk management, compliance, and regulatory oversight.
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Our Client's FDA regulatory group works with broad range of companies, including medical devices, drugs, biologics, diagnostics, digital health, research tools, cosmetics, dietary supplements, wellness products, and other consumer products.
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Demonstrated expertise in credit risk modeling, counterparty credit risk management, market risk management, risk measurement techniques, market-based regulatory capital requirements, and asset pricing.
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In-depth understanding of CMC regulatory requirements and experience with compiling CMC sections for regulatory filings. This position collaborates closely with cross-functional team members, including analytical development, quality assurance, manufacturing and process development, regulatory and clinical operations.
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OPPORTUNITY 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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You will be responsible for building and supporting teams handling product site reliability engineering (SRE), incident management, regulatory reporting, disaster recovery, business continuity planning, automated production testing, and more.
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Crowell & Moring is an international law firm with operations in the United States, Europe, MENA, and Asia. Drawing on significant government, business, industry and legal experience, the firm helps clients capitalize on opportunities and provides creative solutions to complex litigation and arbitration, regulatory and policy, and corporate and transactional issues.
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These activities include, but are not limited to, collaboration on functional area activities during program implementation, clinical study start up/execution/close out, specifically including, medical monitoring, data analysis/reporting and support of Regulatory filings, and clinical development input into regulatory documentation, publications, and scientific presentations.
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Understanding of EMC/EMI testing for regulatory compliance and certification including SAR. Experience with regulatory requirements and process for wireless consumer devices, such as FCC, ETSI, PTCRB, etc.
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Experience working with and building strong relationships with cross-functional departments in business, marketing, hardware and software engineering, product and project management, process and analytical development, regulatory and quality.
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regulatory job Company: Csl Behring in South San Francisco, CA
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