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Associate Director, 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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Allogene is seeking a Senior Director, CMC Regulatory Affairs to provide support for products under development and lead CMC product strategy and provide regulatory direction to quality, manufacturing/tech ops and supply chain teams.
$220,000 - $280,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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The successful candidate will work closely with cross-functional teams, including CMC, analytical chemistry, quality assurance, and regulatory affairs personnel. Cross-Functional Collaboration: Collaborate with external CDMOs as well as internal departments, such as process development, formulation, and regulatory affairs, to ensure alignment and integration of drug substance activities within the overall drug development process.
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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.
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Mammoth is hiring a Director/Sr. Director, Regulatory Affairs, Therapeutics, to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market.
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This Senior Regulatory Affairs Specialist will have an opportunity to work on new to market technology that is improving the field of diagnostic imaging and saving patient lives. Senior Regulatory Affairs Specialist-Remote Based-West Coast.
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We invested in new offices, sector teams and practice groups including investor engagement; shareholder activism; governance; regulatory and public affairs, including geopolitical; crisis; litigation; social issues including climate change and diversity, equity and inclusion; cybersecurity, data and privacy; employee engagement; digital communications; opinion research and analysis, and; creative services.
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Partner with cross functional members across Gilead Pharmaceutical Development & Manufacturing (PDM), including Quality, Supply Chain, Manufacturing, Regulatory Affairs CMC, Finance and Technical Development to ensure successful commercialization of the late-stage portfolio, as well as on time delivery of clinical and commercial product.
$177ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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The Senior Manager/Associate Director, Drug Substance Development and Manufacturing will oversee key scientific, regulatory, and business functions pertaining to process chemistry for the organization.
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Thorough understanding and working experience in drug substance development and manufacturing with respect to GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements.
$205,000 - $225,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Manage regulatory affairs and ensure regulatory compliance of studies, including Institutional Review Board (IRB), National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), Data Safety Monitoring Board, Food and Drug Administration (FDA), and/or other funding or regulatory agency reports.
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In-depth understanding of product characterization of biologics, including monoclonal antibodies and proteinsIn-depth technical understanding of early and late-stage development of biologics products, including CMC Regulatory, Process/Analytical Development, and GMP Manufacturing and QC release and stability testing.
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GENEWIZ is a leading global genomics service company and trusted provider for DNA sequencing, gene synthesis, molecular biology, next generation sequencing, bioinformatics, and GLP regulatory services.
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We are seeking a Manufacturing Development Associate to join our growing team and support Pendulum's current and future commercialization efforts. Maintain records to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and SOPs.
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Experience with clinical trials regulatory affairs, or related clinical trials experience such clinical research coordinator experience. Ensure that all investigators maintain the proper credentials and maintain these records in central regulatory binder (e.g. medical licenses, CVs, GCP/HSP certifications, NCI CTEP registration, SIP accounts, etc.
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regulatory affairs associate manufacturing jobs in South San Francisco, CA
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