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Two (2) years of progressively responsible experience in regulatory affairs, legislative affairs, or energy policy at an electric utility, regulatory agency, or legislative office.
$179,257 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Executive Director, Regulatory Affairs will develop and execute global regulatory strategic and tactical guidance for the development of innovative new drugs in rare disease ensuring fast to market global product registrations, product promotion, maintenance of products and processes in regulatory compliance with local regulations.
$315,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This Regulatory Affairs Manager – Digital Health Technology will work on-site at our Alameda, CA location in the Diabetes Care Division. This Regulatory Affairs Manager – Digital Health Technology will provide support for the regulatory department to ensure efficient and compliant business processes and environment.
$218,500 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The PGDx Regulatory Affairs and Quality Assurance Teams ensures the suitability, safety and effectiveness of next generation sequencing (NGS) medical devices that are developed, manufactured and distributed from our Baltimore, MD site.
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Rocket Pharma is seeking an accomplished and strategic Senior Director of Regulatory CMC to lead our Chemistry, Manufacturing, and Controls (CMC) regulatory affairs. The ideal candidate will possess extensive experience in CMC regulatory affairs, particularly in writing CMC sections for INDs, NDAs, BLAs, and MAAs, as well as strong leadership skills.
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Develop effective collaborations with research project leaders and projects team members, including biostatistics, regulatory affairs, clinical pharmacology, clinical scientists and development operations.
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Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams.
$347,380 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions.
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Provide PV leadership for Jazz Pharmaceuticals Clinical Development including Clinical, Investigator Sponsored, Compassionate Use, and Disease Monitoring Programs; liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs) and other entities to contribute to overall study execution while ensuring safety strategy and operational excellence.
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Collaborate and work cross-functionally with Manufacturing, Regulatory Affairs, Assay Development, Finance, and Quality functions to ensure all activities are scheduled and executed on time in accordance with program timelines.
$225,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This position is hybrid, and based in Santa Monica, CA and reports to the Executive Director, CMC Regulatory Affairs. The AD CMC Regulatory Affairs supports the development and successful performance of the CMC regulatory strategy for the innovative pipeline of early-stage T cell therapies.
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7+ years of experience working with the state Legislature, the Executive Branch, municipal government officials, government relations, public policy, advocacy, government affairs, or campaigns. The Vice President, State Government Affairs will be part of the UHG External Affairs organization, responsible for working with colleagues across External Affairs and the Company to develop and implement strategies on the company's declared state government advocacy, growth, relationship and reputational priorities and overall business advancement initiatives with key state policymakers.
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Develop and support all Quality Management System (QMS) / Regulatory Affairs (RA) activities and functions supporting the quality goals and quality metrics for the site. Collaborates with USDA on regulatory compliance activities including regulatory approvals, import/export compliance, traceability, quarantine, safety testing and affidavits.
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Collaborate across Process Development, Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Finance and Technical Development for successful commercialization of late-stage portfolio.
$328,900 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Special Skills: Must have strong organizational and leadership skills; good problem-solving skills; demonstrate leadership in the areas of food safety and regulatory affairs; possess a thorough understanding of FDA and/or USDA inspected manufacturing facilities; comprehensive experience with FDA and/or USDA Rules and Regulations.
$85,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday
regulatory affairs jobs Title: sr director Company: Iqvia
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