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Michael Wardach Location
Indianapolis, IN, US
Michael Wardach Work
Vice President Regulatory Affairs @ (June 2024 - Present)
VP Global Regulatory Affairs @ (October 2021 - May 2024)
Director, Regulatory Strategy @ (July 2021 - October 2021)
Senior Manager Quality and Regulatory Affairs @ (October 2019 - July 2021)
Sr. Manager Quality and Regulatory Affairs @ (January 2018 - October 2019)
Quality Assurance Manager @ (June 2016 - January 2018)
GMP QA Officer @ (October 2014 - June 2016)
GLP and GCP QA Officer @ (December 2012 - October 2014)
Quality Assurance Auditor @ (December 2010 - December 2012)
Formulations @ (July 2008 - December 2010)
Production Chemist @ (May 2005 - August 2007)
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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