Maria Ines Garcia
US Strategic Director Regulatory Affairs @ Roche
About
I have over 14 years of experience. I am currently US Strategic Director Regulatory Affairs. Previously I was at the FDA where I served as the Assistant Director of the Division of Microbiology devices. I supervised scientific staff who review in vitro diagnostics (IVD) for viral infectious diseases. I have a PhD in Virology with a strong background in IVD validation and regulatory science. I have led multiple teams and projects that have improved the lives of individuals with viral hepatitis and transplant associated infections. My passion is bringing safe and effective diagnostic tests to the US market. This is accomplished through constant learning, collaboration, innovation, and pursuit of excellence.
United States
Silver Spring
Government Administration
protein biochemistry, Cancer Research, breast and prostate cancer therapies, Cross-functional Team Leadership, Test Development, Clinical Microbiology, Hiring, Microbiology, Antibody Tests, Molecular Tests, Regulatory Affairs, Molecular & Cellular Biology, Gene Therapy, Endocrine Disorders, Academic Medicine, Signal Transduction, Diagnostic Assessment, U.S. Food and Drug Administration (FDA), 510(k), Clinical Laboratory Testing
Experience
US Strategic Director Regulatory Affairs
Roche
Assistant Director
FDA
Promoted from Biologist/Scientific Review to Assistant Director.
Biologist/Scientific Reviewer
FDA
Post-Doctoral Scholar (Department of Molecular and Cellular Pharmacology)
University of Miami Miller School of Medicine
Miami, Florida, United States
Graduate Student
Harvard University
Cambridge, Massachusetts, United States
Research Associate
Genetix Pharmaceuticals Inc
Cambridge, Massachusetts, United States
Education
Harvard University
Virology
Massachusetts Institute of Technology
Biology
Maria Ines Garcia's Contact Information
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