Tocagen Inc.
Senior Manager, Regulatory Affairs
Aduro Biotech Sep 1, 2015 - Aug 2017
Manager Regulatory Affairs, Senior Manager Regulatory Affairs
Xoma Mar 2014 - Sep 2015
Manager Regulatory Affairs
Onyx Pharmaceuticals Sep 2010 - Mar 2014
Regulatory Affairs Associate, Ra Associate Ii, Senior Ra Associate, Manager Ra
Onyx Pharmaceuticals Apr 2009 - Sep 2010
Regulatory Operations Associate, Senior Regulatory Operations Associate
Education:
University of California, Berkeley 2009 - 2011
Uc Santa Barbara 2002 - 2007
Bachelors, Bachelor of Science, Biochemistry
Monrovia High School 2002
Skills:
Fda Regulatory Submissions Clinical Trials Clinical Development Ind Sop Pharmaceutical Industry Regulatory Affairs Biotechnology Biopharmaceuticals Ectd Gcp Regulatory Requirements Change Control Gxp Oncology Protocol Document Management Validation Quality Assurance Cro Software Documentation Gmp Cross Functional Team Leadership U.s. Food and Drug Administration Nda Sql Microsoft Excel Microsoft Office Livelink Isi Toolbox 21 Cfr Part 11 Process Improvement Project Planning Technical Writing Clinical Research Capa Medical Writing Ema Regulatory Strategy Workflow Design Cgmp Pharmaceuticals Clinical
Beall Elementary School Frostburg MD 1984-1985, Parkside Elementary School La Vale MD 1985-1989, Southwest Junior High School Palm Bay FL 1988-1989, Braddock Middle School Cumberland MD 1989-1992