Teng Xu
Associate Director, Regulatory Affairs @Incyte
Rockville, MD, US
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MOBILE NUMBERS
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WORK HISTORY
Jan 2023 — Present
Associate Director, Regulatory Affairs @Incyte
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Provide Regulatory CMC strategy for both pre-marketing and post-marketing applications in US, EU and Canada
EDUCATION
2004 — 2008
Dalian University of Technology
Bachelor of Science (B.S.), Chemical Engineering
2008 — 2014
Auburn University
Doctor of Philosophy (PhD), Chemical Engineering
SKILLS
SemOptical MicroscopyUv/VisDscFtirUv-Vis-NirMaterials ScienceChemical EngineeringRheologyDifferential Scanning CalorimetryTemScanning Electron MicroscopyEdxDesign of ExperimentsCfdMatlabImage AnalysisNanomaterialsCharacterizationSpectroscopyLiquid CrystalsTgaNanoparticlesPolymer CharacterizationPolymersIon MillingReliability and Failure AnalysisChemistry
ABOUT TENG XU
5+ year’s regulatory experience as FDA CMC reviewer• CMC review experience for NDAs, ANDAs, INDs, Supplemental NDAs and ANDAs • Participated Pre-Approval Inspection (PAI) including 704 (a)(4) in lieu of on-site inspection
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