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Reporting to the Regulatory Affairs Research Teams Manager, the Regulatory Affairs Specialist-CC 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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Support authoring and manage document workflows for planned major submissions including health authority meeting packages, original INDs/CTAs, and protocol amendments:· Lead interactions with external regulatory submissions vendor· Collaborate with internal project team to facilitate IND/CTA document authoring and review workflows including SharePoint and Master Control responsibilities for regulatory affairs and CMC regulatory.
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The Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Regulatory Affairs Specialist.
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In collaboration with the Regulatory Affairs Administrative Coordinator, he/she will prepare and process all required regulatory documentation for the NCI, the FDA, and certain federal grants, as well as, organize and maintain all regulatory affairs documentation/files as required; including study startup timelines.
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Oversees regulatory compliance in partnership with the Chief Regulatory Affairs Officer, across all Temple campus', including but not limited to Temple University Hospital, Northeastern Campus, Episcopal Campus, Jeanes Campus and Temple outpatient clinics.
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Experience in other Medical Affairs functions (i.e., Publication Planning, Scientific communications, HEOR, etc.) Inizio Engage has a strong partnership with an emerging biopharmaceutical company in endocrinology/rare disease to support Medical Affairs activities and execution.
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Demonstrates Proven Extensive Abilities And Thorough Understanding Of BSA/AML And Sanctions Regulations And Regulatory Authorities And Proven Experience With Working With Banking And Financial Firms Across Multiple Business Areas, Banking, Lending, Trading, Risk Management, Evaluating, Implementing And Developing The Following.
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MSLs are expected to work closely with the Manager of Medical Affairs and the Science Writer & Content Manager to contribute to multiple abstracts and publications each year. The MSL will aid other members of the Medical Affairs team in development of scientific content, and the MSL is responsible for organizing and delivering continuing education (CME/CEU) presentations.
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The director will work closely with GSK Public Policy & Government Affairs as a thought partner on market access implications of proposed policy issues to shape the health policy environment and advance GSK’s policy agenda and will also be responsible for leading teams in price negotiations with state and federal regulators.
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Supervises Curtis’s Senior Associate Dean of Academic Affairs, Senior Associate Dean of Student Life, Senior Director of Scheduling and Logistics Management, Senior Director of Production, Director of Performance Activities, and Director of Academic Operations and Administration to ensure the successful integration of Curtis’s total curriculum, both artistic and academic.
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The Associate Director of Religious and Spiritual Life for Quaker Affairs initiates and supports Quaker-related programming on campus, and serves as the administrative liaison for The Corporation of Haverford College.
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Led by experts in in vivo gene therapy research, with more than 10 years of clinical trial experience, the CIGT team has a wealth of knowledge to navigate the complex safety, regulatory, and clinical care considerations of gene therapy clinical research.
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Duties include sanding, masking, priming vehicle parts and keeping Paint Technicians aware of work progress. The Paint Prepper is responsible for preparing repaired vehicles for refinishing and assisting Paint Technicians with their work.
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Stay updated on industry trends, technological advancements, and regulatory changes related to radiopharmaceutical development and manufacturing and incorporate them into the CMC strategy. Collaborate with cross-functional team leaders, including development, CMC regulatory, manufacturing, and supply chain teams, to ensure seamless execution of CMC strategies and activities.
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Develop and implement a comprehensive program agenda that addresses the core mission areas of the JCRC, including: Deepening understanding of the State of Israel; Responding to antisemitism and anti-Zionism; Building relationships with other faith-based and ethnic communities; Keeping the memory of the Holocaust alive through education programs; Engaging in public policy and government advocacy on local, national, and international issues; and Promoting social and racial justice.
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regulatory affairs keeping jobs Title: regulatory affairs coordinator in Philadelphia, PA
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