Regulatory Affairs CMC, Associate Director @ (May 2016 - January 2018)
Regulatory Affairs CMC, Program Manager @ (September 2014 - May 2016)
Sr. Manager Regulatory Affairs @ (November 2013 - September 2014)
Manager Regulatory Affairs @ (September 2011 - November 2013)
Sr. Regulatory Associate @ (August 2007 - September 2011)
Chemist III @ (August 2007 - August 2008)
Amy Guevara Education
University of San Francisco
BS (Chemistry)
1998-2003
Amy Guevara Skills
FDA
Validation
Regulatory Affairs
GxP
IND
CMC
Quality Control
Clinical Research
eCTD
CTAs
ICH guidelines
Clinical Development
EMEA
Product Development
NDA
Protocol
Good Manufacturing Practice (GMP)
Regulations
Has Errors
Great
Amy Guevara Summary
Amy Guevara, based in Dublin, CA, US, is currently a Executive Director, CMC Regulatory at Jade Biosciences. Amy Guevara brings experience from previous roles at Chinook Therapeutics, Inc., Mirum Pharmaceuticals and CymaBay Therapeutics. Amy Guevara holds a 1998 - 2003 BS in Chemistry @ University of San Francisco. With a robust skill set that includes FDA, Validation, Regulatory Affairs, GxP, IND and more. Amy Guevara has 2 emails and 2 mobile phone numbers on RocketReach.
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