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Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in Research and Development, Regulatory Affairs, and Clinical Development.
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15+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs/small molecules.
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Proven ability to collaborate across departments (Clinical Operations, Translational Research, R&D, Regulatory Affairs, Finance, Manufacturing, Process and Analytical Development.
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Experience and solid knowledge of Pharmacovigilance specificallyProficiency in one or more of these additional areas is a plus: CMC/Mfg., Clinical development and trial execution, Regulatory, Real-World Data and Real-World Evidence, Cell and Gene Therapy, Medical Device, IVD/CDxExperienced in understanding and interpreting regulatory guidelines and documents.
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The CS also has a strategic role in partnership with Medical/Scientific Affairs to develop operating plans and study strategies in support of the Clinical Development and Life Cycle plans.
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He/she will work in close collaboration with Luminex Research Departments, Regulatory Affairs, Scientific Affairs and Sales & Marketing to ensure effective and efficient conduct of clinical research activities in accordance with applicable regulations and standards (e.g. 21 CFR Part 812, CLSI, ICH) that demonstrate the performance and utility of in vitro diagnostic products.
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This individual will work collaboratively with members of all departments within the company, including but not limited to Offshore Wind Development, Onshore Development, Origination, Transmission, Regulatory, and Environmental Compliance & Strategy.
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Incyte Corporation is seeking a motivated and experienced protein purification scientist to provide technical expertise in monoclonal antibody (including bispecifics) purification process development, characterization, and validation primarily for novel therapeutic monoclonal antibody products throughout all stages of clinical trials and commercialization.
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The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
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Conduct assessments and identify areas of improvement to regulatory aspects of drug development and commercial operations; propose and implement process improvementsAll other duties as assigned;The Candidate Bachelor’s Degree in in a life science with 5+ years of experience in Regulatory Affairs, Quality Assurance or related field or any combination in a manufacturing, pharmaceutical and/or GMP facility required.
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Develop effective collaborations with research project leaders and projects team members, including biostatistics, regulatory affairs, clinical pharmacology, clinical scientists and development operations.
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Implement and monitor erosion control, stormwater management, and environmental protection measures throughout the development process to comply with regulatory standards. Proactively address challenges or unexpected issues during the land development process, including weather delays, site conditions, or regulatory challenges.
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Previous experience with genetic medicine, viral vectors, gene therapy, AAV, gene editing drug development/toxicology/regulatory interactions or ocular toxicology/drug development/regulatory toxicology experience is strongly preferred.
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This position reports to the Director of Academic Affairs and is an excellent opportunity to experience various aspects of scholarship and youth development with an educational nonprofit organization.
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Minimum 10 years of experience with biologics and/or cell & gene therapy downstream process development. The ideal candidate should have prior process development experience with common purification techniques such as clarification, chromatography, UF/DF and ultracentrifugation.
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regulatory affairs process development jobs Company: Pfizer in Lahaina, Hawaii
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