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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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The Senior Manager, CMC Regulatory Affairs is a hands-on and independent role requiring a strong individual who will provide strategic and operational support to multiple programs, with an emphasis on CMC (Chemistry, Manufacturing, and Controls.
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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 3 days ago - UpvoteDownvoteShare Job
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Stay current on industry trends, regulatory updates, and legal developments in blockchain, cryptocurrency, and fintech sectors. Guide clients through complex and evolving regulatory frameworks related to blockchain and cryptocurrency.
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Partner cross-functionally with Legal, Commercial, Clinical, Regulatory, Public and Government Affairs, to support cross-functional projects as needed. They will play a critical and exciting role in helping the US Medical Affairs organization support current HIV prevention therapies and potentially launch future HIV prevention pipeline products, with a focus on injectable PrEP. The Associate Director will report to the US HIV Prevention Strategy Lead and will work directly with the US and Global teams.
$247,610 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Bachelor's degree, and 10-12 years of experience in the biopharmaceutical industry or equivalent, with a minimum of 8 years in Regulatory Affairs; advanced degree preferred. The Director, Regulatory Affairs will be responsible for providing global regulatory leadership in support of the development, registration, and lifecycle management of CARGO's oncology products.
$266,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Works collaboratively with others in biometrics (e.g., statistical programmers) as well as with other functional groups such as clinicians, medical and scientific affairs colleagues. Expertise in statistical methods to support medical and scientific affairs including analysis using the clinical database for scientific meetings, publications, and internal decision-making (generally based on previously conducted randomized clinical trials.
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Comprehensive knowledge of GCP, GLP, GMP and other regulations for pharmaceuticals, along with an understanding of global quality standards and regulatory authority inspection trends in relation to product development and commercialization.
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The CMC Regulatory Affairs Sr. Manager at Gilead is responsible for providing strategic direction, operational support, and technical expertise for. Initiates process improvements and contributes to global process improvements, which have a significant impact for the Regulatory Affairs CMC Department or development matrix teams.
$199,320 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Must be fully cognizant and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities. The key functions of this role will be to collaborate with internal and external stakeholders including the Foster City Medical Affairs team, Scientific Publications, Medical Affairs Research, Marketing, Global Commercial Product Strategy, Value and Market Access, Clinical Research, Public Affairs, Government Affairs, Contracts/Finance, Pharmacology, Virology and Legal on both the global and regional levels.
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Reporting to Clinical Research Manager for Radiation Oncology, the Clinical Research Coordinator Associate will be conversant in the goals, mission and priorities of the Institute, and utilize this knowledge to manage data, enroll and follow patients on trial and assist with regulatory and financial requirements of the trials.
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You will also have expertise in one or more of the following areas: (1) B2B marketing and advertising issues; (2) licensing and regulatory issues related to commercial alarm products and monitoring services; and/or (3) privacy and data protection issues in AI, biometrics, and facial recognition technologies.
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Plan, direct, monitor and evaluate the effectiveness of the Disease Control and Prevention activities of the Public Health, Policy & Planning Division including needs assessment, program design and planning, implementation, evaluation and regulatory enforcement.
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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.
$240,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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At least 10 years of experience in pharmaceutical regulatory affairs, that includes, but cannot be limited to, CMC regulatory affairs. Prepares and/or manages submissions that may be technically complex and require extensive interaction with departments outside of regulatory affairs.
$230,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday
regulatory affairs jobs Company: Citi in Foster City, CA
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