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Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
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Build the Regulatory Operations infrastructure and oversee development of standard operating procedures, training materials, and job aids with respect to Regulatory Affairs and Operations.
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As Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC) Manager, you will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously.
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Legislative Initiatives: Oversee the department’s efforts to understand and provide guidance on matters coming before City Council that have an impact on the Streets Department’s operations; supervises the Department’s Legislative and Regulatory Affairs Manager who coordinates such matters on a day-to-day basis.
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Collaborates with Student Affairs and Global Centers to support and improve student and exchange visitor services/initiatives. Masters in Public Administration, MBA, Masters in International Relations, Masters in Higher Education, Juris Doctor, or equivalent preferred.
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Provide medical leadership and guidance to cross-functional teams, including Medical Science Liaisons (MSLs), Clinical Development, Regulatory Affairs, and Commercial Teams. Ensure compliance with regulatory guidelines, industry standards, and company policies in all medical affairs activities.
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The Clinical Research Coordinator (CRC) is an integral and essential member of the ACC CRU Leukemia Research Team. We are looking for an enthusiastic, professional and committed team member to work closely with our clinical research investigators, Research Team Leaders, our clinical research nurse(s), and regulatory coordinator.
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CCRP - Cert Clin Research Prof (Preferred) or RAC - Regulatory Affairs Cert (Preferred) 2 Years experience in a regulatory role or 4 Years experience in related clinical research role (Required.
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Department members continually work with senior members of Customer Operations, Regulatory and External Affairs, Transmission Operations, Finance, Accounting and outside consultants in performing daily responsibilities and supporting strategic initiatives.
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PRIMARY RESPONSIBILITYThis role will lead the Regulatory Operations activities within Global Regulatory Affairs. This role is accountable for managing regulatory submission related activities, providing business ownership and management of IT systems within the scope of Regulatory Affairs, and supporting development of Regulatory Operations procedures and practices.
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The Scientific Affairs Manager is a key member of the content development team who utilizes their combined skills as a scientific medical writer, educational design innovator, and grant development specialist to conduct a turnkey process that includes educational grant development, followed by content development for awarded grants.
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Directs the preparation and submission of regulatory agency applications, reports, and correspondence for opening new studies, protocol amendments, informed consents, continuing reviews, FDA safety reporting, Investigational New Drug applications (INDs), annual reports, Investigational Device Exemption applications (IDEs), etc.
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The incumbent is responsible for analyzing PGW regulatory compliance in communications and actions from regulators and ensuring operating practices are in accordance with local, Commonwealth and federal regulations and requirements.
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Effectively represent the Global Regulatory Affairs (GRA) function in senior-level interactions at internal governance technical review committees, key global health authority meetings, and external partners.
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Penn Carey Law’s Office of Global Engagement (formerly the Office of International Affairs) promotes, develops, and facilitates student engagement with international programming, including study abroad; global fellowships; conferences and research opportunities; student-lead projects; and promotion of global engagement.
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regulatory affairs jobs Title: regulatory affairs specialist Company: Amgen in Philadelphia, PA
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