Mei-Fei Yueh serves as Associate Director in Preclinical/Regulatory Affairs at IQVIA, focusing on regulatory consulting for pharmacology, pharmacokinetics, and toxicology during early drug development phases. Responsibilities include leading preIND and IND submission projects, compiling eCTD documents, authoring nonclinical modules, and managing safety reporting and IND lifecycle as an FDA authorized representative. Previous roles encompass Manager of Global Regulatory Affairs and Senior Regulatory Affairs Specialist, where foundational skills in preclinical writing and regulatory interactions were developed. Prior experience at Hologic involved clinical documentation for FDA submissions, while freelance work included biomedical writing and editing. A solid academic foundation was established with a Ph.D. in Environmental and Molecular Toxicology and an MS in Toxicology from Oregon State University, complemented by a B.S. in Clinical Nutrition from Taipei Medical University.
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