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Incredible opportunity to bring your experience leading CMC Regulatory strategies and your Biologics expertise to Parexel! 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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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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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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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 18 days ago - UpvoteDownvoteShare Job
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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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This Regulatory Affairs Manager - Digital Health Technology will work on-site at our Alameda, CA location in the Diabetes Care Division. This Regulatory Affairs Manager - Digital Health Technology will provide support for the regulatory department to ensure efficient and compliant business processes and environment.
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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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Partners with Sr. Privacy Counsel, Cyber Security, IT, Regulatory Affairs and Enterprise Risk Management to help manage privacy risk exposure. Partners with Sr. Privacy Counsel, Cyber Security, IT, Regulatory Affairs and Enterprise Risk Management to help manage privacy risk exposure.
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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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Currently we are searching for a Regulatory Affairs Manager, this is an onsite role with a hybrid schedule. Bachelor's Degree in Science or Engineering, majoring in Chemistry, Chemical Engineering, Regulatory Affairs, Toxicology, Environmental Policy, or Environmental Science.
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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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Bachelor of Science, International Affairs/Foreign Affairs or similar field with 4+ years of relevant experience OR a Master of Science, International Affairs or similar field with 2+ years of relevant experience.
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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.
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regulatory affairs jobs Company: Parexel
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