2014 -2018 Executive Director Regulatory Affairs CMC @
2013 -2014 Sr. Director, Regulatory Affairs @
2013 -2013 Director, Regulatory Affairs @
2012 -2013 Sr. Program Manager, Regulatory Affairs @
2010 -2012 Regulatory Consultant (full time contractor) @
2009 -2012 Pharmaceutical Industry Consultant @ self employed
2007 -2009 Sr. Director, Project Management and Product Development @
2002 -2006 Project Leader @
1997 -2001 Sr. Scientist @ affymax
1992 -2001 Group Leader @
Usha Ramesh Education
University of California, Santa Cruz
Certificate (Clinical Trials design AND Management)
2006-2007
University of California, Santa Cruz
Certificate (Regulatory Affairs)
2006-2007
University of Mumbai
M.Sc (Organic Chemistry)
University of Mumbai
B.Sc (Physics, Chemistry, Math)
Usha Ramesh Skills
PMP
FDA
Cross-functional Team Leadership
Regulatory Affairs
Drug Discovery
SOP
Pharmaceuticals
GMP
Biotechnology
Quality Assurance
Pharmaceutical Industry
Drug Development
CMC
Clinical Development
Regulatory Submissions
Biopharmaceuticals
GLP
Validation
21 CFR Part 11
Technology Transfer
NDA
CRO
GCP
IND
Clinical Trials
Science
Project Management
Public Speaking
Sales
Regulatory
Molecular Biology
Cross Functional Team Leadership
CMC Regulatory Affairs
Strategy
SAN
Management
Usha Ramesh Summary
Usha Ramesh, based in Cupertino, CA, US, is currently a Vice President, QA and Regulatory Affairs CMC at Summit Therapeutics, Inc.. Usha Ramesh brings experience from previous roles at Gilead Sciences and Pharmacyclics, an AbbVie Company. Usha Ramesh holds a 2006 - 2007 Certificate in Clinical Trials design AND Management @ University of California, Santa Cruz. With a robust skill set that includes PMP, FDA, Cross-functional Team Leadership, Regulatory Affairs, Drug Discovery and more. Usha Ramesh has 2 emails on RocketReach.
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