james little
chief, nonclinical operations
About
Regulatory affairs professional with 21 years FDA-regulated product development experience. Expertise includes nonclinical drug, biologic, and device development supporting conventional as well as chemical, biological, radiological and nuclear (CBRN) threat indications. Regulatory affairs (RAC) and quality assurance-certified (RQAP-GLP) professional accomplished in quality compliance (GLP/GCP/GMP), risk evaluation and mitigation, strategic regulatory path planning, contract and project management, and all drug regulatory operation activities.
united states
washington
government administration
regulatory affairs, compliance, biotechnology, quality assurance, regulatory submissions, medical devices, clinical trials, ind, lifesciences, glp, fda, clinical development, drug development, pharmaceutical industry, gmp, technology transfer, regulatory requirements, validation, life sciences
Experience
research associate
utah biomedical research laboratory
consultant, regulatory affairs and compliance
aclairo pharmaceutical development group, inc.
chief, nonclinical operations
us department of health and human services
regulatory affairs advisor
saic
regulatory affairs manager
aeris therapeutics
senior toxicologist
praecis pharmaceuticals/glaxo smith kline
associate scientist
schering-plough research institute
Education
massachusetts college of pharmacy and health sciences
brigham young university
zoology
james little's Contact Information
Phone
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