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Leads and collaborates in the development of post-approval global CMC regulatory strategies for an approved cell and gene therapy product. The Director, Regulatory CMC (Chemistry Manufacturing Controls) is responsible for the development and implementation of post-approval global regulatory CMC strategies for a marketed cell and gene therapy product.
$200Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Join Takeda as a Director, GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC Pharmaceuticals regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
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Be hands-on and execute lab and small-scale operations to meet project deliverables. Our vaccine client in Boston, MA is looking to add a hands-on, Director, Bioprocess Development (Microbial/Fermentation) to their team.
$200,000 - $240,000 a yearFull-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Leverage your deep knowledge of Regulatory CMC to support our innovative science and allow you to have a major impact on our mission to support our patients. Provide strategic CMC regulatory guidance for global development and registration programs (i.e., IND, CTA, NDA, MAA), working closely within the CMC teams to plan, integrate and align global expectations for development and commercialization.
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Represent Regulatory Writing on cross-functional teams, working in close partnership with regulatory affairs, clinical and nonclinical subject matter experts (SMEs) from pharmacology, drug metabolism and pharmacokinetics (DMPK), toxicology, and other internal stakeholders and external collaborators/CROs.
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The Associate Director, Regulatory CMC executes multi-product global regulatory CMC strategies for cell therapy combination investigational and marketed products. Provides CMC regulatory guidance to cross-functional teams and key stakeholders.
$200Full-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide program leadership and develop CMC regulatory strategy for global vaccine programs in various stages of development.
$169,400 - $266,200 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Hands-on experience with EDR solutions (e.g., CrowdStrike, Carbon Black). Familiarity with regulatory and compliance frameworks (e.g., GDPR, PCI-DSS, HIPAA). Check out our career site for more information on perks and benefits and reach out to our Talent Acquisition team for region specific benefits.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Strong subject matter expertise in immune-oncology, cell therapy drug discovery and development including CMC considerations, CAR design, engineering and armoring strategies, innate immune cells such as NK and gamma delta for the purposes of leading drug development projects from start to the clinic.
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Partner closely with Research, Development, Clinical, Commercial, CMC, Regulatory Affairs and other G&A functions to ensure alignment on program strategy, priorities, timelines, resources, budget, and deliverables, ensuring that strategy is reflected in the program operations.
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Must have direct experience in Regulatory Affairs CMC for biologics/vaccines or cell and gene therapies, with a demonstrated track record of significant accomplishments (e.g. successful IND, leading health authority interactions on CMC topics.
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Strong hands-on experience in protein biophysical characterization techniques such as DSF, DSC, SEC-MALS, DLS, Octet, CE, icIEF, HPLC-based assays (SEC, HIC, IEX, etc.) We seek an enthusiastic scientist with extensive hands-on experience, broad knowledge in a variety of advanced biophysical characterization techniques, and strong cross-functional collaborative mindset in a fast-paced environment.
$150Full-timeExpandApply NowActive JobUpdated 30 days ago - UpvoteDownvoteShare Job
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A Catalio Capital backed start-up that is a preclinical biopharmaceutical company focused on the development of compounds targeting tumor metabolism is seeking a Vice President of CMC. · Responsible for all CMC sections of regulatory filings including FDA, EMA and other national authorities to support the conduct of clinical trials.
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5+ years working in the pharmaceutical industry, with an emphasis on authoring CMC regulatory content. Plan, manage and execute the authoring and review of CMC regulatory documents and deliver on timelines for submissions.
$101,900 - $123,400 a yearFull-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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The successful candidate will be a hands-on product development engineer that will support our medical device design and product development efforts. If you’re a self-described hands-on engineer with initiative and a knack for problem solving, you’ll fit right in.
$150ExpandApply NowActive JobUpdated Today
hands on cmc regulatory jobs Title: operations in Boston, Schuyler, Nebraska
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