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Under the supervision of the Regulatory Program Manager of the Regulatory Review Unit, the Assistant Regulatory Affairs Coordinator (ARAC) supports the clinical research efforts of the 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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People: We have transitioned thousands of officers into successful careers in law enforcement, government services, foreign affairs and many more. About Inter-Con Security Passion: Joining the Inter-Con family is an opportunity for growth in an environment that truly cares for its employees.
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Ability to establish and maintain effective working relationships across the UC Irvine Health Affairs and work effectively with diverse stakeholders, especially physicians Ability to form and maintain effective relationships with a diverse set of stakeholders internal and external to the organization.
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Knowledge of regulatory requirements and industry standards related to access control and SOD, such as SOX, GDPR, HIPAA, and NIST. Stay abreast of emerging trends, technologies, and regulatory developments in SOD and access management, and recommend enhancements to policies and procedures.
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EEC specializes in the fields of soil/groundwater investigation/remediation; environmental/regulatory compliance; civil environmental engineering, wastewater and stormwater consulting; construction, and GIS/databases processes.
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Experience managing the entire cell-based assay lifecycle from development, Tech transfer, to commercial and being involved in the BLA/MAA regulatory submissions. Contribute to the preparation and review of CMC (Chemistry, Manufacturing, and Controls) documentation, particularly focusing on the analytical sections required for regulatory filings(BLA/MAA), including post-approval submissions to US and EU regulatory bodies.
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This position will supervise a team of marketing student workers and collaborate with members of the CPD and key campus partners, including school/college-based career liaisons and marketing colleagues, Strategic Marketing and Communications (SMC), Engagement and Volunteerism, Student Affairs, and the Communications Council.
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Using fundamental technical skills, analytical abilities, and up-to-date regulatory knowledge, provide complete customer oriented, environmental analysis, planning and compliance solutions, to assist clients in areas of CEQA/NEPA permitting and regulatory compliance.
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Experience evaluating analytical test data for wastewater treatment solids and wastewaters in regard to suitability for agricultural crop production, calculation of appropriate application rates, regulatory limits, and monitoring requirements for site soils, crop, groundwater, and surface water.
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Extensive experience in statistical programming related to clinical trials analysis, reporting and regulatory submissions. Medical Affairs and HEOR. Ensure quality and timeliness of statistical analysis, reporting, and regulatory submission deliverables, addressing challenges with agility.
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Experience with AERMOD, GIS and/or health risk assessments for permitting, ambient monitoring or emissions sampling techniques, CEQA, or other regulatory compliance programs (e.g., SPCC, RMP/PSM, stormwater) is a plus.
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Responsible from Medical Affairs for the design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses.
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License(s) or Certification(s) in Certified Internal Auditor ("CIA"), Certified Public Accountant ("CPA"), or Certified Regulatory Compliance Manager ("CRCM") desired, but not required. Strong knowledge of GAAP principles And Regulatory and banking Policies and Procedures.
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LHH Recruitment Solutions is seeking a fulltime Legal Practice Assistant with at least 5 years of business litigation experience (IP, Corporate, Commercial, Real Estate, Banking, Regulatory and White-Collar law.
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Delivering quality patient care to all patients at all times, and maintaining operating rooms in accordance with the professional and regulatory standards, philosophy and goals, set forth by Hoag Hospital.
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regulatory affairs jobs Company: Delta Companies Inc in Irvine, CA
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