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Kyverna is seeking an experienced and passionate Associate Director, CMC Regulatory Affairs with a strong background in cell and gene therapy, preferably CAR T therapy. Minimum 3-5+ years of CMC Regulatory Affairs experience with direct experience in cell and gene therapy, preferably CAR T therapy.
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Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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D., Masters and Ph. D. preferably majoring in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology or Biology- RAC certification a plusExperience:- 7 years or more of CMC regulatory experience in the pharmaceutical industry with a history of successful of investigational filings and approvals of marketing applications as the CMC Regulatory lead.
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Two (2) years of progressively responsible experience in regulatory affairs, legislative affairs, or energy policy at an electric utility, regulatory agency, or legislative office.
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Specific responsibilities include Quality Systems, FSMA, HACCP, GFSI/BRC, regulatory audits, food safety training, Regulatory Affairs, Plant Quality Assurance, Vendor Compliance, and Consumer Affairs.
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Supporting the Head of U.S. Government and Regulatory Affairs and Head of the DC Office to develop and execute a Washington, DC public policy strategy with the U.S. Congress, U.S. Administration, and U.S. regulatory agencies.
$175,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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5 year prior experience in regulatory affairs within the dietary supplements or food industry, especially experience with an ingredient supplier is highly preferred. o Lead and execute regulatory affairs on customer documentation requests.
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The person in this role specifically interacts with the Faculty Directors of McCourt academic programs, the Associate Dean of Student Affairs, McCourt Communications and Events staff, student organization leaders, and numerous student resources at Georgetown as they support McCourt students and the Office of Student Affairs suite.
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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 3 days ago - UpvoteDownvoteShare Job
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Working hand-in-hand with R&D, Regulatory Affairs, Legal, and Brand teams, they make sure all scientific communication is spot-on and compliant. Collaborate with the R&D, Regulatory Affairs, Legal, and Brand teams to ensure alignment on product claims and scientific communication.
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Broad experience in US and Global Regulatory Affairs, including experience with INDs, BLAs/NDAs, MAAs, Pediatric Investigation Plans, Orphan Drug designations, rare disease drug development, innovative trial design and/or expedited regulatory pathways.
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Oversees Business Affairs / Talent manger. Oversees all talent billing & production advances with support from Business Affairs manager. A minimum of 7 years of experience specific to the advertising industry in a Business Affairs Role.
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Our work depends on Regulatory Affairs Manager joining our team to contribute to PKI and Identity Management policy development, technical liaison and advisor. Seize your opportunity to make a personal impact as a Regulatory Affairs Manager supporting a PKI Government High Value Asset Mission Essential Function program.
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Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) Genmab is looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.
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The Manager, Regulatory Affairs at 4D Molecular Therapeutics will be supporting Global Regulatory Lead(s) with regulatory submissions (e.g., IND, CTA, expedited programs, and marketing applications) by leading one or more countries to ensure the successful progress of 4DMT’s product pipeline toward regulatory approval and commercialization.
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regulatory affairs jobs Title: affairs associate Company: Modis
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