Executive Director , Regulatory Affairs CMC @ (April 2020 - September 2023)
Executive Director, CMC Regulatory Affairs and Ad. Promo @ (February 2018 - April 2020)
Executive Director Regulatory Affairs CMC @ (July 2014 - February 2018)
Sr. Director, Regulatory Affairs @ (August 2013 - July 2014)
Director, Regulatory Affairs @ (April 2013 - August 2013)
Sr. Program Manager, Regulatory Affairs @ (January 2012 - April 2013)
Regulatory Consultant (full time contractor) @ (January 2010 - January 2012)
Pharmaceutical Industry Consultant @ self employed (November 2009 - January 2012)
Sr. Director, Project Management and Product Development @ (March 2007 - November 2009)
Project Leader @ (January 2002 - January 2006)
Sr. Scientist @ affymax (January 1997 - January 2001)
Group Leader @ (January 1992 - January 2001)
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
Michigan State University
PhD (Organic Chemistry)
University of Mumbai
M.Sc (Organic Chemistry)
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, Pharmacyclics, an AbbVie Company and Pharmacyclics. 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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