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What we look for: A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD. Demonstrated organizational leadership skills at both functional and enterprise levels.
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10+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs and small molecules.
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Under the supervision of the Regulatory Program Manager (RPM) of the Regulatory Affairs Unit, the Regulatory Affairs Coordinator (RAC) supports the clinical research efforts of the Chao Family Comprehensive Cancer Center by providing comprehensive, regulatory management of cancer-related protocols in accordance with human subject federal regulations, internal standard operating procedures (SOPs), and University policies and procedures.
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D. graduates in various areas of industry pharmacy including regulatory affairs, medical information/affairs, patient safety, outcomes research, and many other areas. is offering a two-year Health Economics and Outcomes Research (HEOR) / Medical Affairs PharmD fellowship based in Newton, MA.
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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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Western Digital is seeking a Vice President of Government Affairs and Policy to build an impactful government relations program and team to advance the company’s public policy agenda and represent the company’s interests on government policy at the federal, state and local level.
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We are seeking an innovative and highly motivated Principal Scientist, Scientific Affairs who will contribute significantly to the development and continued growth of our advanced cell therapy manufacturing platform.
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Collaborate with the Executive Associate Dean of Academic Affairs and the Assistant Dean of Student Affairs, in providing leadership for recruitment and selection processes of students accepted into academic non-degree, non-certificate special programs.
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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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Associate Economist, Regulatory Affairs. Economic Analyst, Government Affairs. Cherokee United Services (CUS) is seeking a Mid-Level Regulatory Economist to join our dynamic team in Washington DC. In this role, you will play a key role in conducting economic and regulatory analyses, supporting project management activities, and contributing to business development efforts.
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Collaborate across Process Development, Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Finance and Technical Development for successful commercialization of late-stage portfolio.
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Experience drafting regulatory documentation across all stages, including IND, BLA, and MAA submissions. Draft and approve CMC sections in regulatory filings, support agency interactions and inspections.
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The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
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Strong interest in government affairs/regulatory affairs. There is also the Washington, DC Policy Team and the Communications Team, as well as the NBC Government Affairs Team and the NBC Regulatory Team. These different teams that all work collaboratively on a daily basis, guide the company with how it interacts with policy makers.
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Develop and support all Quality Management System (QMS) / Regulatory Affairs (RA) activities and functions supporting the quality goals and quality metrics for site. Collaborates with USDA on regulatory compliance activities including regulatory approvals, import/export compliance, traceability, quarantine, safety testing and affidavits.
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regulatory affairs jobs Company: Travelnursesource in ME, Germany
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