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The Director of Board and Executive Affairs serves as a key member of the Vice President's office by providing administrative and project management support. Ability to travel and attend off-campus appointments and events.
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Position SummaryThe Director of Board and Executive Affairs serves as a key member of the Vice President's office by providing administrative and project management support. Within URAD, the departments of Development, SDSU Alumni, Planned Giving, Special Events, Donor Relations, Marketing and Communications, Financial Management, Data Management, Prospect Research and Management and Operations are making a difference in the lives of SDSU’s 37,000 students.
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Position Summary: The Head of Regulatory Affairs will be a key member of the executive team, responsible for developing and executing regulatory strategies to support the clinical development and commercialization of our cell therapy products.
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The VP, Compliance oversees a team of direct reports working to ensure licensing and regulatory requirements are met, reports are filed accurately on a timely basis, and regulatory and agency examinations are managed appropriately.
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In collaboration with AbbVie About The Role Addresses a broad array of legal matters to support the Company’s Commercial, Corporate Affairs, IT, Research, Development, Clinical, Regulatory, Manufacturing, Medical Affairs, Business Development, Alliance Management and/or general administrative departments.
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Interest or experience in environmental planning and regulatory compliance (California Environmental Quality Act, National Environmental Policy Act, and National Historic Preservation Act (Section 106) and historic preservation.
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Collaborate closely with internal stakeholders, including R&D, regulatory affairs, and medical affairs, to integrate clinical development strategies into overall product development plans.
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The division of Medical Education within the UC San Diego School of Medicine consists of the following units: Undergraduate Medical Education, Admissions & Student Affairs, Diversity and Community Partnerships, Graduate Medical Education, Continuing Medical Education & Faculty Development, Simulation Education, Physician Assistant Education, Anatomical Services, Business Affairs and Educational Technology.
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The Financial Operations organization is responsible for the financial and budgetary controls and procedures of San Diego State University (the University) and reports to the Vice President for Business and Financial Affairs through the Associate Vice President for Financial Operations.
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Knowledge of CAP, CLIA and FDA regulatory requirements and experience working in CAP, CLIA and/or FDA accredited laboratory. Knowledge of Macintosh and PC related software, Microsoft Excel, FileMaker Pro. Knowledge of Master Control or other document control/quality management software.
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Serve as project manager for the development of CEQA/NEPA documentation, associated technical studies, regulatory permitting, and public outreach following guidelines from Caltrans, FHWA, and others.
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Financial Operations consist of Budget and Finance; Procure to Pay; Audit and Tax; and the University Controller's Office, which includes Accounting Services, Financial Reporting, Bursar's Office, Financial Systems Management & Analysis, and the SDSU Card Office.
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Bachelor's degree or equivalent in a life science and 8+ years of experience in regulatory affairs in the pharmaceutical/biotech industry. Individual must have prior project regulatory leadership experience with specific focus on the CMC aspects for small molecules, large molecules and/or gene therapies, including detailed knowledge of FDA and EMA regulations and guidance for drug development, preparation and management of IND/CTA/MAA/NDA/BLA. Prior experience with preparation and preferably, negotiation to marketing approval in major markets is desirable OR.
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This will be accomplished by working in close collaboration with colleagues in Commercial, Regulatory, Market Access, Clinical Development, Corporate Affairs, Patient Advocacy and other key cross functional areas.
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Collaborates with other Educators/CNS-s to ensure staff support, continuing education and training materials that provide support for appropriate documentation in the EMR of quality patient care that meets specialty and other regulatory standards.
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regulatory affairs jobs Title: travel registered nurse in San Diego, East-hartford, Connecticut
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