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We believe that our PCVs could receive regulatory approval based on successful completion of clinical studies utilizing well-defined surrogate immune endpoints, consistent with how other PCVs have obtained regulatory approval in the past, rather than requiring clinical field efficacy studies.
$144,000 - $162,000 a yearFull-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Camio already has a number of interesting case study customers, including Stanford University (DOD), Altria (regulatory compliance) and Delta Airlines (via NewRest/TSA for safety risk). Additionally, expertise in navigating complex regulatory landscapes and understanding the specific needs of governance, risk, and compliance applications would be valuable.
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Partner with internal customers (e.g. scientists, medical affairs, clinical development, reimbursement, regulatory, operations, business development and sales/marketing) to build customer and product requirements for Guardant CGDB-based portfolio.
$131,040 - $253,000 a yearFull-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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The Principal Regulatory Affairs Specialist will be part of this high-performance team and responsible for developing regulatory strategies, preparing U.S. and major market submissions and obtaining approval to introduce new spinal implants and biologics worldwide.
$150,801 - $207,351 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Identity Governance and Compliance : Implement identity governance processes to ensure compliance with regulatory requirements and industry standards, such as GDPR, HIPAA, SOX, and PCI DSS. Solid understanding of regulatory compliance requirements and data privacy laws.
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Adicet Bio is seeking an exceptionally talented and motivated individual to join our team as a regulatory associate I/II. This position will be responsible for supporting the Sr. manager of regulatory affairs and assisting in developing and executing regulatory activities in support of the CMC, nonclinical, and clinical development for our early development pipeline products within the Regulatory Affairs department.
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Parvus’ leadership team is experienced in successful drug discovery, development, manufacturing, regulatory approval, and commercialization. Navacims™ specifically target and act only on disease causing effector T cells, delivering a signal that programs effector T cells to differentiate into regulatory T (Treg) cells specific for self-antigens relevant to the patient’s disease.
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In this position, you will work closely with the Process Development, Quality Control, Analytical Operations, Quality Assurance, Translational Medicine, Biometrics, and Regulatory team members and will contribute to flow cytometry-based assay development for product understanding of CARGO Therapeutics' pipeline candidates, method transfer and/or qualification, SOP/technical report authoring and review, method life cycle management, data analysis, and execution of routine analytical testing.
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Medical Strategy: Develop and execute the medical affairs strategy in alignment with corporate goals, ensuring the integration of medical initiatives with clinical development, regulatory affairs, and commercialization efforts.
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This Process Engineer role requires close working relationships with Manufacturing, Analytical Development, Supply Chain, Quality, Regulatory and CMC Program Management functions as well as with external CMO teams.
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Works collaboratively with Clinical Operations, Formulation Process Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory, Outsourced Manufacturing and Project Management partners to develop optimal supply strategies and ensure on time delivery of clinical supplies to initiate and resupply studies with investigational medicinal product (IMP.
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The Director, Formulation Development for Pre-pivotal Biologics will be responsible for leading first-in-human formulation development strategies and enable successful pre-pivotal regulatory filings for biologics in multiple therapeutical areas.
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Stay current with regulatory requirements on CDISC and clinical regulatory programming standards. In-depth knowledge of CDISC SDTM and ADaM specifications and associated regulatory guidances.
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About Stanford University’s Hoover Institution: The Hoover Institution on War, Revolution, and Peace is a public policy research center devoted to the advanced study of economics, politics, history, and political economy—both domestic and foreign—as well as international affairs.
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This investigation includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent). We assist companies and non-profit organizations in delivering benefits to their employees.
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regulatory affairs jobs Title: sr director Company: Merck in Foster City, CA
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