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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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Work across a variety of functions involved in drug development, such as preclinical, clinical, regulatory, biostatistics, and medical affairs. As a Clinical Pharmacologist, the Associate Director/Director will be responsible for designing, conducting, and analyzing clinical pharmacology studies, as well as providing expert advice on pharmacokinetic and pharmacodynamic aspects of drug development and regulatory submissions.
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As a Sr. Toxicologist for this industrial chemical company, you will be hands on in risk assessment, regulatory affairs, EU Reach, leading consortia/industry association meetings, and serving external stakeholders.
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The Product Safety Toxicologist will report directly to the Regulatory Affairs Director. We are seeking an experienced regulatory toxicologist as a Product Safety Toxicologist for our global Regulatory Affairs organization.
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Provide regulatory guidance, general issue management and strategic stakeholder engagement support to Corporate Affairs and business leaders. Humana Director Public Policy, State Affairs Salt Lake City , Utah Apply Now Become a part of our caring community and help us put health first.
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Humana Director Public Policy, State Affairs Montgomery , Alabama Apply Now Become a part of our caring community and help us put health first. Reports to the VP, Strategy & State Affairs-Corporate Affairs Administration.
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From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.
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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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Key ResponsibilitiesStrategy and Execution:Uses an understanding of disease biology, the drug development process (particularly cross-functional connectivity), and relevant late-stage challenges (e.g., trends in disease area therapeutic advances, and evolving regulatory, patient advocacy and market access environments) to create a vision for each asset, then design and execute effective development programs in support of the overall R&D portfolio goals.
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This position will work collaboratively with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations.
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Fifteen (15) years of experience in Regulatory Affairs and Quality experience in the biotechnology, medical devices, or pharmaceutical industry with increasing responsibility (including interfacing with FDA and other regulatory agencies in development and commercialization of new medical technologies.
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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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Regulatory Affairs Manager *PC Regulatory Affairs - Waltham MAAt Miltenyi Biotec, 3, employees worldwide develop pioneering solutions for biomedical science and the clinical application of cell therapies.
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Prepares clinical study documents and coordinates with additional collaborators including product management, statistician, regulatory affairs, clinical research management, and contract research organizations (CROs.
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Developing knowledge of the Specialty franchise & the Medical Affairs/HEOR organization and proactively guiding commercial, medical and regulatory clients. Working cross functionally with Commercial, Medical Affairs, Regulatory Affairs, the Office of Ethics and Compliance, Public Affairs, and other departments to find solutions to meet business objectives consistent with the law, applicable policies/procedures, and AbbVie’s Code of Conduct.
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regulatory affairs jobs Title: assistant Company: Banner Health
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