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The Regulatory Affairs Manager is responsible for managing regulatory activities in the U.S. and being a business partner to other teams. Regulatory Affairs Manager-Bel Chicago.
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Working knowledge of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety/pharmacovigilance, and regulatory affairs. Effectively collaborate with the operational project team members and stakeholders from CMC, Finance, Legal and Regulatory Affairs as necessary regarding performance (KPIs) related to clinical study vendor(s) ensuring compliance with study specifications (i.e., timelines, deliverables, budgets) and applicable SOPs.
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Professional accreditation such as a Certified Regulatory Compliance Manager (CRCM), Certified Internal Auditor (CIA), Certified Risk Professional (CRP), and Certified Anti-Money Laundering Specialist (CAMS) is preferred.
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Will draft, track, and manage DoD/legislative affairs reporting requirements as they pertain to DARPA and DARPA requirements/responsibilities. 3+ years of experience on congressional committee staff/related legislative affairs experience with a national security focus.
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The Administrative units include the Offices of the Dean, Vice Dean, Associate Dean for Student Affairs, Associate Dean for Research, Associate Dean for Clinical Affairs, Associate Dean for Extramural Clinical Practices, Assistant Dean for Dental Education and Informatics, Assistant Dean for Educational Support and Faculty Development, Assistant Dean for Academic Success and the Assistant Dean for Business Operations and Financial Affairs.
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ATEC’s Scientific Affairs team is responsible for regulatory, testing, and research activities in support of the company’s initiatives. The Clinical Research function, as a sub-function of Scientific Affairs, includes planning, coordinating, and overseeing the successful execution of preclinical and clinical research studies and large-scale data collection efforts in partnership with our surgical practice partners.
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We’re a leader in staffing Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, HEOR, Market Access, and Sales & Marketing roles. Hematology/Oncology MSL Expansion – Top BioPharma CompanyTMAC’s direct-hire service, formerly known as TMAC Direct, is an executive search firm and Pharma’s Complete Recruiting Resource.
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This position presents an opportunity to work with the Associate Dean of Student Affairs to build upon the early stages of our academic skills program to further support our student population.
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Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide program leadership and develop CMC regulatory strategy for global vaccine programs in various stages of development.
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Expertise in commercial healthcare and FDA regulatory law, specifically related to market access, pricing and price reporting, patient support, government contracting matters, and other laws and regulations related to the development and commercialization of pharmaceutical products.
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Product Sales Regulatory Compliance:Adheres to compliance of Centers for Medicare and Medicaid Services (CMS), California Department of Health Care Services (DHCS), and L.A. Care's Regulatory Affairs & Compliance regulatory guidelines.
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Experience in academic affairs, advising, student support services, enrollment management or student affairs. The AVPAA will report to the Provost and Vice President for Academic Affairs, working closely with the senior academic team to reinvigorate the institution's student success agenda.
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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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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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The AD develops a collaborative and productive partnership between the athletics department and academic affairs, student affairs, enrollment management, university relations, and other administrative units to advance the university's mission through Royals Athletics.
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regulatory affairs jobs Title: intern Company: Amgen
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