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The Regulatory Affairs Specialist will be responsible for supporting regulatory strategy, conducting regulatory research, producing technical reports to support regulatory implementation or commercialization of new products and processes in the dental/orthodontic area.
$80,000 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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The Regulatory Affairs Specialist (RAS) positions are critical to successfully achieving ongoing clinical research expansion and regulatory compliance at DFCI. The Regulatory Affairs Specialist (RAS) positions provide advanced expertise and regulatory support to 600+ investigators and research staff members at DFCI, focusing on standards and techniques for performing job functions typical in the development and/or conduct of FDA regulated research from an operational and regulatory compliance perspective.
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7+ years’ experience in clinical research/development/real world evidence (RWE) function; (medical devices preferred) Strong scientific background in the development of evidence generation and clinical evaluation / RWE and research methodologies, including innovative clinical trial design, registries, quality improvement initiatives, and creation of data networks and working knowledge of biostatistics.
$97 an hourExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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The Department of Biomedical Informatics is the academic home for over 30 tenure-track faculty who use genome-scale biology, multiscale modeling, mathematical physiology, simulation, machine learning, artificial intelligence, knowledge engineering, human-computer interaction, data integration, and mathematical and predictive analytics to marry disparate but related aspects of the campus's clinical and research portfolios.
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Whether you have worked at research universities or barely know what CRISPR is, you see the transformational potential of biomedical research and want to contribute to advancing the field with your expertise.
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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.
Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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The Director / Sr. Director, Regulatory Affairs will be responsible for developing and executing innovative CMC regulatory strategies in support of the global development and commercialization of a drug/device combination product.
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Reporting to an Associate Director, CMC Regulatory Affairs, the successful candidate will work independently and collaborate cross functionally to provide guidance to the CMC subject matter experts and manage and execute CMC regulatory submissions to facilitate the global development of Avidity compounds.
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Contribute to ongoing process improvement and department initiatives within the CMC Regulatory Affairs function, including process improvements, SOP review and development, development of training, etc.
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This position will report to the Integrative Medicine Manager and work in partnership with Fred Hutch Cancer Center's Public Health Sciences and Clinical Research Divisions. With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the worlds leading cancer, infectious disease and biomedical research centers.
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We research, develop, and commercialize innovative digital health products and solutions by bringing together the full capabilities of our team, including product strategy and management, clinical expertise, partnerships, UI/UX design, usability research, clinical research and validation, software development, AI / Gen AI, and regulatory.
$207,750 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.
Full-timeRemoteExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD. Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.
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At the forefront of medical discovery as it relates to understanding the causes of obesity, diabetes, cardiovascular disease, cancer and dementia, Pennington Biomedical Research Center is a campus of Louisiana State University and conducts basic, clinical and population research.
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Technology: Biomedical research has become increasingly dependent on complex tooling. Bachelor’s degree in communications, human resources, psychology or another relevant field required; Master’s in Higher Education Administration / Student Affairs preferred.
$44 an hourFull-timeExpandApply NowActive JobUpdated 3 days ago
clinical research regulatory affairs biomedical jobs Company: Bd in TX, Us
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