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Shao-Yu Li

Regulatory Affairs Specialist

24 followers

New Taipei City, New Taipei City, Taiwan

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Timeline
About me
QA Manager
Education
- National Taipei University of Education
  2004 - 2008
  Bachelor of Science (B.S.) Science Education (Biology and Chemistry) 85.9
  Majored in Biology and ChemistryElectived Earth Science and Physics
- National Chung Hsing University
  2009 - 2011
  Master of Science (M.S.) Life Science 89.8
  Topic：Study on the specific inhibitors of human m-NAD(P)+-ME
Experience
- Taidoc Technology Corp.
  Nov 2011 - Apr 2013
  Regulatory Affairs Specialist
  - QSD application- Product registration to TFDA and CFDA - Technical documents writing
- National Synchrotron Radiation Research Center
  Jun 2013 - Nov 2013
  Research Assistant
  - Protein crystallography experimental station maintenance. - Protein crystallization and structure analysis
- Lihpao Life Science Corp.
  Aug 2014 - Apr 2016
  Product Division Deputy Director
  - Developed regulatory strategies and timeline for product development.- Provided guidance on regulatory compliance.- Supervised the IVD kit manufacturing and improved the process.- Managed and prepared the applications of GMP and ISO13485 for IVD kit.- Developed DNA vaccine with lactobacillus shuttle vector.
- Sysmex Corporation
  Aug 2016 - now
  Quality Assurance Specialist
Licenses & Certifications
- GEPT (High- Intermediate)
  The Language Training & Testing Center
  Feb 2009
  View certificate