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Knowledge and experience in clinical and CMC regulatory affairs for pre-licensed and clinical RA for licensed biologic product or vaccine. As a Director, Regulatory Affairs, Vaccines you will e nsure the development and execution of the appropriate Regulatory strategy(ies) for assigned US asset(s), across all stages of the product life cycle and consistent with the Vaccines Development Strategy/Integrated Asset Plan (IAP.
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Legal Services, Government, Law Enforcement, Government Administration, Public Administration, Public Policy, Judiciary, Regulatory Administration, Law and Legal Services, Legal & Regulatory Affairs.
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This position will collaborate with the Senior Public Affairs Manager and leadership to develop and implement a Public Affairs strategy designed to achieve the Agency’s advocacy goals - including public education, direct lobbying of elected officials, and grassroots community organizing.
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Manage regulatory affairs and ensure regulatory compliance of studies, including Institutional Review Board (IRB), National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), Data Safety Monitoring Board, Food and Drug Administration (FDA), and/or other funding or regulatory agency reports.
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Reporting to: Senior Director, CMC Regulatory Affairs, The Manager/Sr. Manager, Technical Writing - CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs plays a critical role in ensuring compliance with regulatory requirements pertaining to drug development and manufacturing processes.
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The Living Therapeutics Initiative seeks a highly motivated Regulatory Affairs Senior Manager to manage the regulatory affairs, author and assemble IND applications, and help manage FIH studies advancing UCSF-developed cellular therapy candidates.
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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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Reporting to the Senior Vice President, Global Regulatory Affairs, this key senior leadership role serves as a recognized regulatory policy leader and influential spokesperson in support of Amgens global regulatory initiatives.
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The Associate Principal Scientist will work closely with individuals from PaCES, Clinical Research, Regulatory Affairs, Biostatistics, Outcomes Research, and Operations to ensure COA endpoint strategies are consistent with and correctly executed to support the product strategy.
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As the Director of Regulatory Affairs Operations, reporting to the Vice President of Regulatory Affairs and Quality Assurance, you will develop and lead global regulatory operations to support the advancement of multiple clinical trials.
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Individual assists with compliance assignments associated with the LRE generating fleet, as well as, other entities required to comply with the Standards and Requirements of the North American Electric Reliability Corporation (NERC), specifically, the Critical Infrastructure Protection (CIP) Standards, the Regional Reliability Organizations, Independent System Operators, Federal Energy Regulatory Commission (FERC) and Department of Energy.
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The CRU Regulatory Affairs Office seeks a full-time Regulatory Affairs Veeva Quality Assurance Specialist to participate in the review and migration of Phase I-V clinical trial investigator site files to the Veeva SiteVault platform.
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Monitor and improve tracking/control systems for regulatory inquiry responses. may be considered if applicable to product being supported) OR previous experience with servicing or supporting the product or comparable products in the field OR previous experience developing responses to regulatory inquiries.
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The individual will support teams on the development, validation, analysis, and interpretation of COA endpoints to support regulatory submissions, reimbursement evidence dossiers, payer interactions, and publications.
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Job Description PharmaLex is one of the largest worldwide providers of consulting services in the following focus areas: Quality Management & Compliance; Development Consulting & Scientific Affairs; Regulatory Affairs; and Pharmacovigilance, Epidemiology and Risk Management.
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regulatory affairs jobs Title: regulatory assistant Company: Jobget
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