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The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
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Evaluate and advise senior management, the VP, Legal Affairs & Deputy General Counsel and the Chief Legal Officer on regulatory and privacy legal issues relating to Company products/services in conceptual or development phases to include data usage rights, as well as on appropriate legal courses of action to meet strategic Company goals for product deployment, revenue, and strategic initiatives.
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Associate Director, CMC Regulatory Affairs. The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions.
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The Federal Regulatory Affairs Manager will collaborate closely with the North America Team Leader and business-lead Vice Presidents to develop regulatory strategies to ensure registrations are obtained and maintained to meet business objectives and timelines.
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Partners with Sr. Privacy Counsel, Cyber Security, IT, Regulatory Affairs and Enterprise Risk Management to help manage privacy risk exposure. Partners with Sr. Privacy Counsel, Cyber Security, IT, Regulatory Affairs and Enterprise Risk Management to help manage privacy risk exposure.
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High comfort providing healthcare regulatory advice (Anti-kickback law, FDA, government affairs, antitrust). Ability to work closely with, facilitate interactions within, and influence large cross-functional teams (including representatives from other areas of the law department, regulatory and compliance professionals, and Oncology Ecosystem colleagues.
$258,800 a yearFull-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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15+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs/small molecules.
$113 an hourFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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A minimum of 6-10 years experience in product stewardship, regulatory affairs, compliance, chemical consultancy, and/or risk assessment. The ideal candidate will have experience in chemical and environmental regulatory compliance, packaging regulations, product stewardship and industrial risk management in the medical device or manufacturing industries.
$175,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The Director of Regulatory Affairs and Customer Compliance is responsible for overseeing and providing leadership for all regulatory and export compliance matters within the MFI Integrated Supply Chain.
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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 13 days ago - UpvoteDownvoteShare Job
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Team with business unit Regulatory Affairs Specialists (RAS) to provide regulatory support for new product introduction (NPI) and marketed products under MDD and MDR Regulation. As Principal Regulatory Affairs Specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide regulatory bodies.
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The Counsel position will be an integral part of the Regulatory, Operations, Government Affairs and Environmental team. The Counsel will assist the Deputy Chief Counsel and Principal Counsel on various transactional, operational and regulatory legal matters primarily for Disney Signature Experiences (with a focus on Disney Cruise Line) and also the Walt Disney World Resort.
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Familiarity of the AML/CFT and sanctions regulatory environment for digital assets globally, including the BSA, OFAC and other sanctions regulations, and travel rule requirements. 12+ years of combined in-house/Biglaw experience, including leading regulatory coverage, preferably in fintech, banking, payments, capital markets or other institutional financial services.
$270,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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8+ years relevant experience in quality control, quality assurance, and regulatory affairs at a Class I or Class II medical device manufacturer. Coordinate and organize test data and clinical or scientific reviews in support of regulatory submissions.
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Instructors may be engaged for courses in the degrees in Global Economic Affairs, Global Environmental Sustainability, Human Rights, International Development, International Security, International Studies, and Public Policy.
$7,456 a monthInternExpandApply NowActive JobUpdated 1 month ago
regulatory affairs jobs Title: intern Company: County Of Orange
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