Bensheng Liu
Regulatory Affairs Director
- Role
- Director, Regulatory Clinical Strategy at Eikon Therapeutics
- Location
- New York, NY, US
- LinkedIn followers
- 500 followers
About Bensheng Liu
Regulatory strategist with working knowledge of FDA and EMA regulations, ICH guidelines…
Experience
Director, Regulatory Clinical Strategy
Jan 2024 — Present · Jersey City, NJ, US
Lead global regulatory strategy for two oncology assets with multiple ongoing and planned clinical studies in early and late development stages; Led preparation and executed successful FDA type C and Type B pre-IND meetings, led preparation and submitted an initial IND; Manage global CTAs in over twenty countries as regulatory lead, oversee and execute regulatory interaction with global MoHs directly and via CROs; Lead pediatric development, secured positive PIP decision, authored PSP and led negotiations with FDA
Education
Michigan State University
Doctor of Philosophy (Ph.D.)
Northwestern University
Master of Science - MS
Nanjing University
Bachelor of Science
Skills
- Immunohistochemistry
- Qpcr
- Enzyme Assays
- Molecular Biology
- Fluorescence Microscopy
- Cell Biology
- Genetics
- Pcr
- Biochemistry
- Elisa
- Molecular Cloning
- Mass Spectrometry
- Gc-Fid
- Microscopy
- Rt-Pcr
- Gas Chromatography
- Gel Electrophoresis
- Spectrophotometry
- Protein Expression
- Confocal Microscopy
- Western Blotting
- Uv/Vis
- Assay Development
- Cell Culture
- Bioinformatics
- Protein Chemistry
- Microbiology
- Sds-Page
- Uplc
- Analytical Chemistry
- Cell
- Scientific Writing
- Dna
- Fluorescence
- Rna Isolation
- Lc-Ms
- Hplc
- Protein Purification
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