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Under the direction of the Senior Director, this position collaborates and regularly meets with key stakeholders, including Clinical Research Disease Center Managers, CTO Associate Directors of Regulatory Operations, Regulatory Affairs, Network and Satellite Program, Project Management / Monitoring and Education and Training to promote excellence and streamlined collaboration in clinical research across all disease groups.
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Ten years of progressively responsible student affairs leadership experience, adult education or higher education administration experience including seven (7) years of management oversight and supervisory experience required.
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Certification in quality management (e.g., ASQ Certified Quality Auditor) or regulatory affairs (e.g., RAPS Regulatory Affairs Certification) preferred. Minimum of 5 years of experience in quality assurance and regulatory affairs within the food & beverage, dietary supplement, pharmaceutical, or related industry.
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Government Relations and External Counsel: Working with Global Scientific & Regulatory Affairs and Global Governmental Affairs, build and maintain relationships with regulatory agencies, industry associations, and external legal counsel to stay informed about regulatory changes and emerging issues.
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The director will partner broadly with campus constituents such as but not limited to Development/Alumni Relations, LGBTQIA+ Center for Faculty & Staff, Residence Life/Housing, Student Activities, Howard Thurman Center for Common Ground, Student Health Services, Community & Inclusion, Government/Community Affairs, the Newbury Center, International Students and Scholars Office, and Athletics.
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Develop and integrate timelines and budgets for clinical pharmacology activities with overall company timelines and goals, in close coordination with project management, clinical science, CMC, DMPK, nonclinical development, regulatory affairs and other stakeholders.
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Student Affairs, academic or work experience related to the fields of social work, community organizing, arts & media organization, student affairs, counseling psychology, race & ethnic studies.
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The Head of Regulatory Affairs US will report to the Head of Legal Affairs US. This position will handle a wide range of regulatory affairs matters, including providing legal advice and counsel across various sectors, functions, and business units both in the United States and internationally.
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The Senior Director, QARA is principally responsible for the development and implementation of the Company’s quality assurance program through the development and implementation of quality assurance and compliance standards via policies and procedures, training, auditing and monitoring, facilitating internal reporting, compliance-related investigations, and keeping Third Party Logistics VP of Quality Assurance & Regulatory Affairs informed on quality assurance and regulatory affairs matters.
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QualificationsTo be considered for this role, you’ll require a minimum of 5 years of professional experience in relevant field of healthcare products or related activities e.g.:Work in medical devices industry and/or in vitro diagnostic devices(preferred) or closely related industries (e.g., pharmaceutical industry) such as research and development, manufacturing, quality management, regulatory affairs.
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Complete audits to assess accuracy and quality of scientific data submitted to the regulatory agencies in support of in vivo medical devices and in vitro diagnostic devices' application. Project manage auditing teams, as appropriate, to improve efficiencies, enhance client satisfaction and ensure compliance with standards.
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Bachelors degree in Business, Economic, Public Affairs, or any utility regulatory process development field plus five (5) years of related work experience. The candidate filling this position will serve as coordinator across Austin Energy and the broader Texas stakeholder community for a wide range of ERCOT market and regulatory policy issues.
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Support Hoxworth Blood Center’s safety, cGMP, and Quality Plan in coordination with the Division Director, Quality and Regulatory Affairs. It ensures effective qualification, use, maintenance, calibration, and repair of medical equipment used in the provision of blood, blood components, tissues, and derivatives in accordance with safety standards and regulatory requirements.
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Under the direction of the Division of Academic Affairs, the Speech Language Pathologist (SLP) / SAIL Program Coordinator will facilitate programs and activities for students and families enrolled in our Social Assistance in Learning (SAIL) Program.
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Experience in legislative affairs, policy, or lobbying. You will be responsible for effective communications, managing business processes, and building coalitions and diplomacy within the federal space for ARPH's legislative affairs department.
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regulatory affairs jobs Title: regulatory affairs project manager Company: Gpac
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