VP, Regulatory Affairs and Quality Assurance @ (September 2007 - September 2011)
snr director regulatory affairs @ ALZA Corporation (January 1985 - January 2007)
Kim Gaumer Education
Stanford University 1979-1983
Kim Gaumer Skills
Development of Global Regulatory Strategy
Global Regulatory Compliance
ISO 13485
Team Leadership
eCTD NDA and European MAA lead- multiple programs
GxP
Quality System
FDA GMP
Regulatory Affairs
Strategic Planning
Marketing
Pharmaceutical Industry
Project Management
Public Speaking
Process Improvement
GMP
IND
ISO 22000
Strategy
CMC Regulatory Affairs
Kim Gaumer Summary
Kim Gaumer, based in Mountain View, CA, US, is currently a Snr. Vice President, Regulatory and Quality Assurance at AcelRx Pharmaceuticals. Kim Gaumer brings experience from previous roles at AcelRx Pharmaceuticals, Zosano Pharma and ALZA Corporation. Kim Gaumer holds a 1979 - 1983 Stanford University. With a robust skill set that includes Development of Global Regulatory Strategy, Global Regulatory Compliance, ISO 13485, Team Leadership, eCTD NDA and European MAA lead- multiple programs and more. Kim Gaumer has 2 emails and 1 mobile phone numbers on RocketReach.
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