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Michael Wardach Location
Indianapolis, IN, US
Michael Wardach Work
2024 -now Vice President Regulatory Affairs @
2021 -2024 VP Global Regulatory Affairs @
2021 -2021 Director, Regulatory Strategy @
2019 -2021 Senior Manager Quality and Regulatory Affairs @
2018 -2019 Sr. Manager Quality and Regulatory Affairs @
2016 -2018 Quality Assurance Manager @
2014 -2016 GMP QA Officer @
2012 -2014 GLP and GCP QA Officer @
2010 -2012 Quality Assurance Auditor @
2008 -2010 Formulations @
2005 -2007 Production Chemist @
Michael Wardach Education
San Diego State University-California State University
Master of Science (MS) (Regulatory Affairs)
2014-2017
George Mason University
B.S. (Chemistry, Biochemistry Concentration)
2004-2008
Michael Wardach Skills
Oecd
Good Laboratory Practice Glp
CRO
Computer System Validation
GMP
GxP
Biotechnology
Regulatory Affairs
Life Sciences
Validation
Quality Assurance
Protocol
Pharmaceuticals
Biopharmaceuticals
Drug Development
u.s. Food and Drug Administration Fda
Pharmaceutical Industry
GLP
CAPA
FDA
Sop
21 CFR Part 11
GLPs
Good Laboratory Practice
u.s. Food and Drug Administration
Michael Wardach Summary
Michael Wardach, based in Indianapolis, IN, US, is currently a Vice President Regulatory Affairs at Z-Alpha Therapeutics. Michael Wardach brings experience from previous roles at Telix Pharmaceuticals Limited and Zevacor. Michael Wardach holds a 2014 - 2017 Master of Science (MS) in Regulatory Affairs @ San Diego State University-California State University. With a robust skill set that includes Oecd, Good Laboratory Practice Glp, CRO, Computer System Validation, GMP and more. Michael Wardach has 1 emails and 1 mobile phone numbers on RocketReach.
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