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Comprehensive understanding of related disciplines (biostatistics, regulatory affairs, pharmacology, toxicology, cell therapy manufacturing, clinical pharmacology, and pharmaceutical sciences.
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CMC Regulatory Affairs, oncology, small molecule, drug development, clinical development. 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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Serve as the PDM regulatory representative on project teams, provide CMC regulatory support for the clinical development of the investigational product(s), and ensure applicable regulatory requirements are appropriately met.
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The position is responsible for leading CMC regulatory activities within the Regulatory Affairs department, to support all ORIC’s clinical development programs of oncology products.
$235,000 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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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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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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Responsibilities:– Ensure compliance with regulatory requirements for working with animals in biomedical research, including the Animal Welfare Act & Regulations, the Guide for the Care and Use of Laboratory Animals, local policies, and other applicable regulations.
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Our research programs encompass a broad range of biomedical research activities and areas of study, focusing on various fields such as cardiovascular disease, alcoholism, hematopoietic cancer, behavioral research, aging, and gene therapy.
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Position Summary Clinical Veterinarian The Laboratory Animal Resource Center (LARC) at a prestigious institution is seeking a customer service-oriented individual to join our team as a clinical laboratory animal veterinarian and Assistant Director.
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Provide veterinary preventive, clinical, diagnostic, technical, and surgical services, with a focus on USDregulated species, frogs, laboratory mice and rats. Serve on department, campus, and university committees as assigned (e.g., IACUC, IBC.
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Ensure compliance with regulatory requirements for working with animals in biomedical research, including the Animal Welfare Act & Regulations, the Guide for the Care and Use of Laboratory Animals, local policies, and other applicable regulations.
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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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Serve on department, campus, and university committees as assigned IACUC, IBC). Review IACUC and IBC protocols and provide post-approval monitoring. Stay updated on issues in laboratory animal medicine, animal care, and science.
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Bachelor’s degree required – preferably in research administration, healthcare administration, business administration, legal or regulatory studies, biomedical, science, or another research-related field.
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However, qualified individuals with documented past academic rank advancement may qualify for the associate scientist faculty rank. At LARC, we provide comprehensive care and housing for multiple species of laboratory animals, with a primary emphasis on swine, dogs, rabbits, frogs, and rodents.
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clinical regulatory affairs biomedical jobs Company: Bd in TX, Us
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