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Experience in advertising and promotional regulatory affairs activities through launch and commercialization are a plus. The VP, Regulatory Affairs will provide strategic regulatory expertise to support the continued development and the commercialization of acoramidis for the proposed treatment of ATTR-CM and the prevention of ATTR. This role involves collaboration with cross-functional project teams in planning and execution of development strategies while providing leadership to global regulatory submissions.
$305,000 - $365,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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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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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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As a deputy to the executive director of Public Affairs, the Director will ensure the integration of UCSF Health's marcomm strategies with the Public Affairs team's media relations and owned content strategies supporting UCSF's clinical, research, education, public service missions.
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AA&PI Student Services is part of the Division of Equity & Community Inclusion under Student Affairs & Enrollment Management. Work in collaboration and partnership with other programs, departments, and areas within Student Affairs & Enrollment Management and in Academic Affairs to support Pacific Islander student needs for program planning, course advisement, major and career exploration.
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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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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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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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Build and maintain an expanded level of knowledge and expertise in CCR model risk management and related supervisory guidance, including existing regulatory requirements and guidance from relevant SR letters, proposed rules and guidance from the U.S. regulatory agencies, and standard methodologies identified during Federal Reserve horizontal reviews.
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Prepare, review, or edit cGMP batch records, CMC regulatory and Quality documents. The candidate will be responsible for chemical development-related activities across the portfolio including process development and manufacture of regulatory starting materials (RSMs) and support production of Drug Substance (DS) for clinical trial materials, and establishment of associated Control Strategy for RSMs and DS to support NDA/MAA filing and commercial manufacturing.
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Be a strategic partner to Pliant's Research, Clinical, Pipeline Marketing, Legal, Business Development, Regulatory Affairs and Human Resources teams as well as employee-centric including Employee Experience and Diversity, Equity, and inclusion (DEI.
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Experience with R&D, Brand, Quality Assurance / Quality Control, Regulatory Affairs, Clinical, Manufacturing environments regulated by the FDA. This position is responsible for the business analysis, planning, project management, implementation, computer systems validation and ongoing support of business applications in the areas of Research & Development Analytical, Regulatory Affairs, Clinical, Quality Affairs and Quality Control.
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Reporting to the Head of Regulatory Affairs, this individual will be responsible for assuring the regulatory strategy is aligned with Health Authority requirements and regulatory submissions are on time and of high quality.
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The Software and Systems group within Tax Reporting & Strategy (TRS) offers management consulting services to clients and to their large corporate tax functions, by monitoring and analyzing legislative and regulatory tax developments, developing strategies in anticipation of tax law changes and regulatory developments, analyzing the economic impact of tax legislation and federal budget proposals, and addressing technology needs for tax function effectiveness.
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regulatory affairs jobs Title: sr Company: Csl Behring in Brisbane, CA
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