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We are accountable for enabling our programs in early research to reach development candidate nomination through regulatory filing and into clinical trials. How you will Achieve More with Intellia:Intellia is look for a Director, Genotoxicity Regulatory Lead to support the advancement of genome editing products into the clinic.
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Leads nonclinical submission working groups to liaise effectively with cross-functional team members (Clinical, Global Patient Safety, Program Management, Global Regulatory, Regulatory Operations, Drug Discovery Units, DMPK&M, and Drug Safety Research and Evaluation) to recognize aims, align on strategy, define executable timelines, and agree upon content for nonclinical regulatory submissions.
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Preferred knowledge in thermal analysis, X-ray powder diffraction, contributions to synthetic chemistry, and regulatory documentation. Proficient in organic chemistry tools (HPLC, LCMS, GC, NMR) and software (ChemDraw, Excel.
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Familiarity with regulatory requirements and compliance in equity capital markets. This is a brand-new role for the firm, reporting to our CO-Chief Investment Officer and will offer an exciting opportunity to become a pivotal partner in shaping our equity capital markets strategy.
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Ensures compliance within guidelines set forth by regulatory agencies (DPH, ERISA etc.) Comprised of Tufts Medical Center, Lowell General Hospital, MelroseWakefield Hospital, Lawrence Memorial Hospital of Medford, Care at Home - an expansive home care network, and large integrated physician network.
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Under the direction of the Senior Director, Accreditation & Regulatory and working collaboratively, the Accreditation and Regulatory Specialist (Nurse) leads efforts to ensure continual organizational compliance and ongoing readiness with clinical quality and patient safety standards and regulations required by The Joint Commission, Massachusetts Department of Public Health and Center for Medicare and Medicaid Services.
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The Clinical Leader participates in planning, organizing, implementing and evaluating patient care and developing programs to support clinical care consistent with the mission and goals of Brigham & Women’s Faulkner Hospital as well as the requirements of JCAHO and other applicable federal, state and local regulatory and/or accrediting agencies.
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Global health regulatory agency knowledge and experience across GxP life cycle in Cell & Gene therapy and/or Biologics. The role will be responsible for supporting the development of the cell therapy quality strategy to meet business, regulatory, and operational requirements.
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Hands-on experience with data monitoring and vendor operations, data collection, data-entry, data-monitoring, data-validation, discrepancy management, data-extraction, and IRB/regulatory requirements.
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Collaborate with cross-functional teams, including analytical development, process development, quality assurance, and regulatory affairs, to ensure seamless project progression. Deep understanding of regulatory requirements and quality standards in pharmaceutical manufacturing.
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Broad knowledge of accounting practices and procedures and investment related regulatory requirements (ERISA, DOL, IRS, SEC, FASB, NRC, FERC, etc.) The Tufts Investment Office, located in downtown Boston, oversees three distinct pools of capital, incorporating endowment and other long-term assets critical to the university, and is led by Chief Investment Officer Craig Smith.
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Simcere is seeking a Senior Scientist to join our preclinical team to help advance our discovery programs evaluating novel immune regulatory therapies to treat autoimmune and inflammatory diseases.
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Regulatory Compliance: Ensure all trading activities comply with market rules and regulatory requirements set by the Independent System Operators (ISOs), Regional Transmission Organizations (RTOs) and Federal Energy Regulatory Commission (FERC.
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Knowledge of the Lacey Act, FDA, EPA, Customs Modernization Act, Tariff Act, and other regulatory requirements related to customs clearance and import/export classifications. Oversee import/export operations from origin to final destination, ensuring adherence to all legal and regulatory requirements.
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Clear understanding of the drug development process, submission-related activities and regulatory requirements (e.g., CDISC, CDASH, eCTD) and guidelines (e.g., ICH, CHMP, FDA, GCP). Our lead product candidate, pridopidine, holds Orphan Drug Designation in both Huntington’s disease (HD) and Amyotrophic lateral Sclerosis (ALS) in the U.S. and EU, as well as Fast Track designation from the FDA for the treatment of HD. Prilenia is working on preparing for a potential regulatory filing for HD and for starting a global phase 3 in ALS with pridopidine.
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regulatory job in Dorchester Center, MA
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