Su-Lin Lee
Director, Regulatory Affairs CMC
- Role
- Director, Regulatory Affairs Cmc at Pacira BioSciences, Inc.
- Location
- San Diego, CA, US
- LinkedIn followers
- 500 followers
About Su-Lin Lee
10+ years of US and EU regulatory CMC experience (industry and FDA) in clinical development and commercial drug program regulatory filings- Regulatory Affairs Professional with extensive knowledge of current regulatory policy priorities in US, EU and Global Regulatory Affairs- 11+ years of drug discovery research experience in various therapeutic and disease areas
Experience
Director, Regulatory Affairs Cmc
Oct 2024 — Present · San Diego, CA, US
Education
National Chung Cheng University
Bachelor's Degree, Chemistry
1998 — 2002
The Ohio State University
Ph.D., Medicinal Chemistry
2007 — 2012
National Taiwan University
MS, Pharmacy
2002 — 2004
Skills
- Structure/Ligand-Based Drug Design
- Immunoprecipitation
- Biacore Spr
- Nmr Spectroscopy
- Isothermal Titration Calorimetry (Itc)
- Organic Chemistry
- Structure Modification of Natural Products
- Rt-Pcr
- Total Synthesis
- Hplc
- Dna/Rna Extraction
- Middle-Scale Reaction
- Mammalian Cell Culture
- Retrosynthetic Analysis
- Protein Chemistry
- Drug Design
- Chemistry
- Quantum Mechanical Calculations
- Lc-Ms
- Western Blotting
- All Kinds of Chromatography
- Radiometric in Vitro Kinase Assay
- Biochemistry
- Nmr
- Cell Proliferation Assays
- Ligand-Receptor Docking Prediction
- Gene Transfer/Knockdown
- Molecular Biology
- Microwave Reaction
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