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10+ 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 and small molecules.
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Regulatory Affairs: Prepare and review regulatory submissions related to DMPK, including INDs and NDAs. Interact with regulatory agencies as needed to address DMPK-related inquiries and ensure compliance.
$265,000 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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In collaboration with the Clinical Affairs Lead and Medical/Scientific Lead, prepares strategy decisions, presents and discusses data at relevant team, governance, external consultants, KOL and potentially regulatory meetings.
$269,400 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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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 Yesterday - 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 1 month ago - UpvoteDownvoteShare Job
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The science writer internship will be a hybrid, part-time position that will be embedded in regular content meetings and publication calendars through the Strategic Communications & External Affairs.
InternExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Interfaces with Chief Medical Officer/Medical Monitor and cross-functional team members including Data Management, Drug Safety, Logistics/Manufacturing, Project Management, Regulatory Affairs, and Biostatistics.
Full-timeExpandApply NowActive JobUpdated 6 days ago - 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.
Full-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Serve as USMA Head of HIV Treatment in cross-functional meetings, representing the US perspective and needs in working groups with Clinical Development, Global Medical Affairs, US Commercial, US Government Affairs and Policy, US Public Affairs, US Regulatory, and US legal and compliance.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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As the Director of Regulatory Affairs , you will be responsible for developing and implementing global strategies to secure and maintain market approval for BillionToOne product(s). Regulatory Affairs Certification (RAC) a plus.
$350,000 a yearFull-timeExpandApply NowActive JobUpdated 27 days ago - UpvoteDownvoteShare Job
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Vice Provost for Student Affairs, Stanford, California, United States. Administer, implement, and interpret university and department policies and procedures and advise or refer on issues regarding financial aid, housing, registrar and academic services, International student services, student engagement, academic advising, and career counseling and placement.
ExpandApply NowActive JobUpdated 7 days ago - 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.
$55 an hourExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Collaborate with regulatory affairs to ensure compliance with applicable medical device regulations and standards throughout the development lifecycle. - Define project requirements, specifications, and timelines in collaboration with cross-functional teams, including engineers, researchers, medical professionals, and regulatory specialists.
$215,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Collaborate with cross-functional teams including biostatisticians, project management, clinical data managers, scientific affairs, medical affairs, and regulatory affairs to ensure timely and accurate delivery of statistical programming deliverables.
$174,182 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Reporting to the Chief Operating Officer (COO), the Regulatory Services Program Manager will oversee regulatory staff and ensure services are delivered in accordance with Insignia’s standards.
$200,000 a yearExpandApply NowActive JobUpdated 25 days ago
regulatory affairs jobs Company: Bluepipes in Foster City, CA
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