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5 + years of experience in global CMC regulatory affairs. Key responsibilities include leading the preparation and maintenance of CMC/quality sections for regulatory submissions, serving as the CMC regulatory representative on project teams, and providing regulatory assessment and guidance on CMC-related change controls, deviations, and investigations throughout the product lifecycle.
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Lead early and late-stage drug product development activities including scale-up, design of experiments (DOEs), risk assessments, and development of the integrated control strategy in partnership with other CMC functional areas, Quality, Regulatory Affairs, and Manufacturing.
$200,000 a yearFull-timeExpandApply NowActive JobUpdated 25 days ago - UpvoteDownvoteShare Job
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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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The incumbent will report directly to Head of CMC Regulatory Affairs – Systems and Operations at Gilead. In addition, the Sr Director will be accountable for leading the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally.
$307,560Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Vice President, Regulatory Affairs and Quality Assurance implements regulatory strategies worldwide to 1) ensure that regulatory requirements are met, and 2) obtain regulatory approval for Pulmonx products.
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Preferred Experience: 2-3 years Oncology Regulatory Affairs experience. Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.
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Reporting to the Vice President, Regulatory Affairs, the Senior Director, Regulatory Affairs – CMC will be responsible for leading, developing, and executing CMC regulatory strategies on programs ranging from early to late-stage development, including preparation and filing of IND and NDA/MAA submission.
$270,000 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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The Senior Manager or Associate Director for BBOT Regulatory Affairs will be a strategic thinker responsible for overseeing (with support) the regulatory assessment and research on regulatory precedence to evaluate regulatory strategies for development programs focused on precision medicine.
$195,000 a yearFull-timeExpandApply NowActive JobUpdated 2 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.
Full-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.
$309,140 a yearFull-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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Interact with document authors, contributors, and reviewers (including members of Biometrics, Clinical Operations, Clinical Development, Project Management, CMC, Drug Safety, and Regulatory Affairs) to acquire necessary input into documents.
$250,000 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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We are looking for an Associate Director/Director, Regulatory Affairs CMC to join our team. Minimum 8-10+ years progressive Regulatory Affairs experience; 6+ years with an advanced science-related degree.
$240,000 a yearFull-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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Work closely with clinical operations, regulatory affairs, and other departments to ensure smooth study start-up processes. Prepare and submit regulatory documents required for study start-up, including IRB/EC submissions and regulatory agency applications.
$70 an hourFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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The position requires a strong skillset and experience in strategic planning, stakeholder management, and coordination of interdependent project activities across several functions, such as clinical operations, regulatory affairs, and government accounting.
$175,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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We are seeking an innovative and highly motivated Scientist, Scientific Affairs who will contribute significantly to the development and continued growth of our advanced cell therapy manufacturing platform.
$210,000 a yearFull-timeExpandApply NowActive JobUpdated 22 days ago
regulatory affairs jobs in Burlingame, CA
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