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Director, CMC Regulatory Affairs. 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.
ExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
RemoteExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Reporting to the Director of Regulatory Affairs, the Senior RA Specialist will collaborate with global team members, cross-functional teams, and stakeholders. You’ve acquired a minimum of 7 years' Regulatory Affairs experience within FDA regulated, complex Medical Device/Software (SiMD/SaMD) environments, including leadership/guidance on global regulatory strategy for 510K’s, CE Marking per MDD, EU MDR (updating Technical Files), Worldwide product registrations, Design Dossiers, PMA, clinical evaluations, Post Market Surveillance and reviewing Marketing Communication materials for promotional purposes.
Full-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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Interact with R&D, Marketing, Regulatory, Medical and Scientific Affairs, and other global functions as well as senior leadership teams and global partners to apply advanced critical thinking to build strategic plans for new biomarker development, stakeholder management, and technology dissemination such as Real-World Evidence, ensuring benefit from the new capabilities and opportunities these enable.
$185,500 - $235,500 a yearFull-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Advanced degree in Science, Healthcare, or Regulatory/Clinical Affairs. The Clinical Affairs Director for Beckman Coulter Diagnostics is responsible for leading comprehensive global clinical trial strategies to support the complex Clinical Chemistry and Immunoassay Biomarker-Flywheel (Biomarker) program and for managing a multi-level team of clinical managers and clinical scientists/affairs associates.
$185,500 - $235,500 a yearFull-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Reporting to the Regulatory Affairs Research Teams Manager, the Regulatory Affairs Specialist will, with minimal supervision , prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
RemoteExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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R&D CMC Regulatory Affairs Chemical Products Scientist/Sr. Scientist page is loaded. R&D CMC Regulatory Affairs Chemical Products Scientist/Sr. Scientist. As a staff member of CMC Regulatory Affairs Department of Japan Development Division, a person in charge who is willing to contribute in CMC Regulatory Affairs (RA) tasks from initial stage of new drug development to NDA filing and the approval, addition of dosage form, and change controls.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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At GSK, our Biopharm CMC regulatory affairs group is responsible for a portfolio of biopharmaceuticals products. As a Manager, Biopharm CMC Regulatory Affairs, you will direct the CMC regulatory activities of multiple projects and dosage forms.
Full-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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The Regulatory Affairs Manager will work out of our Maple Grove, MN location for our Electrophysiology division. Regulatory Affairs Manager - Electrophysiology page is loaded.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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You will be a part of the CCIA Clinical Affairs team and report to the Senior Director Clinical Affairs responsible for managing the CCIA portfolio for the Clinical Affairs department.
$117ExpandUpdated 6 days ago - UpvoteDownvoteShare Job
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In-depth knowledge of CMC regulatory requirements for Advanced Therapy Medicinal Products and have an understanding of current global and regional trends in CMC Regulatory Affairs for such products.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Clinical chemistry, immunoassay FDA & EU or Class III medical device experience with broad knowledge of medical device industry, regulatory requirements, and frameworks. This position is part of the Chemical Chemistry and Immunoassay (CCIA) Clinical Affairs department located in Chaska, Minnesota and can be remote.
$185,500 - $235,500 a yearFull-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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The individual will support Director and/or Sr. Director Hepatology/Virology to ensure project plans integrate and align with the product strategic plans from matrix teams to maintain leadership in Hepatology/Virology.
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To do these effectively, the Analyst III – Policy & Regulatory Operations must have a demonstrated understanding of IEHP business operations and responsibilities of various departments in Health Services, Quality Systems, Provider Services, and Member Services; subject matter expertise of these departments’ policies and procedures and the regulations that drive their business operations and demonstrated ability to effectively and consistently manage multiple projects and priorities concurrently.
$80,059.2 - $106,059.2 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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They will be responsible for coordinating submissions to local regulatory bodies including the Institutional Review Board (IRB) under the supervision of the Regulatory Affairs Manager.
ExpandApply NowActive JobUpdated 8 days ago
regulatory affairs jobs Title: sr director Company: On Time Talent Solutions
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