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Strong knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, and Good Clinical Practice. We are looking for someone who already has an interest and established foundation in regulatory affairs and human subjects research, and/or specialized knowledge of working with cellular therapies.
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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.
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Reports to: Associate Director, Analytical Development. Extensive expertise in U/HPLC, CE, SDS-PAGE, mass spectrometry, and other analytical technologies as applied to protein analytical method development, trouble shooting and validation for GMP release and stability testing.
$144,000 - $162,000 a yearFull-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Associate Director, Regulatory Affairs Advertising and Promotion page is loaded. Associate Director, Regulatory Affairs, Labeling. Associate Director, Regulatory Affairs Advertising and Promotion.
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Support regulatory filings by authoring/reviewing CMC regulatory sections of IND/INDa; support associated agency interactions and product-related inspections. 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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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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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 4 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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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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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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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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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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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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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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Furthermore, as the Director of Facilities, you are responsible for providing guidance and oversight of the regulatory compliance program of the college for City of Waterloo, Waterloo Fire Dept., State of Iowa, including the DNR, EPA and OSHA. In our position, you will be out and about on campus working with many college personnel, vendors and various community organizations.
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regulatory affairs jobs Title: sr regulatory affairs associate in Redwood City, CA
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