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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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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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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.
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Review, validate and approve regulatory label content and compliance documentation (i.e., supplier affidavits, 3rd party certificates, product lab test results) uploaded by suppliers into the Private Brands Product and Packaging Specification system for record-keeping and to substantiate on-package claims.
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This role primarily involves supporting Medicare, Medicare Advantage, and other value based care business initiatives as well as advising on general healthcare regulatory matters. We are looking for a Healthcare Regulatory counsel to join our Legal team.
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The Regulatory Affairs Business Risk Officer is a first line professional within the Wholesale Banking division managing and assisting the business with regulatory adherence with a strong focus on BSA/AML, change management and people manager of a first line KYC team.
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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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We are currently seeking a Head of Quality & Regulatory Affairs BPS (x|f|m) for our BPS division. Deep familiarity with all quality functions including quality control, quality assurance, validation, regulatory affairs, and EHS.
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Maintaining compliance and records of those, along with being the primary interface for all wind and solar assets under the Exus portfolio for all regional and regulatory entities, including FERC, NERC, NERC Regional Entities, AESO (and other Canadian Regulatory Entities), DOE, and EIA.
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Regulatory Operations team is responsible for reporting to external stakeholders in the North America region, including the reporting and monitoring of trade, transaction and position information across a wide range of traded financial products and business lines for the CFTC (Commodity Futures Trading Commission), SEC (Securities and Exchange Commission), and CSA (Canadian Standards Association) obligations.
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Join us as an Associate Director - Nonclinical Regulatory Writer and Submission Support reporting to the Nonclinical Regulatory Writing and Submission Support, GI2 and NS Products Team lead, based in Cambridge, MA/Virtual.
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We are seeking an in-house lawyer with specialized experience advising on regulatory and statutory matters in the renewable energy (solar or battery storage) and /or EV charging space in the United States.
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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.
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Associate Director, Nonclinical Regulatory Writing and Submission Support, Gastrointestinal and Inflammation (GI2) and Neuroscience (NS) Products. Regulatory Affairs Credential (RAC-Drugs) is an advantage.
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regulatory job Title: regulatory affairs associate Company: Modis
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