Michael Matthews

Director of Regulatory Affairs @Sabin Vaccine Institute

Frederick, MD, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Nov 2023 — Present

Director of Regulatory Affairs @Sabin Vaccine Institute

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Washington, DC, US

Develop and execute regulatory strategies for filovirus vaccinesProvides regulatory subject matter expertise in Animal Rule, accelerated approval, emergency use authorization (EUA), and traditional approvalProvide regulatory input for clinical, nonclinical, and manufacturing developmentDevelop regulatory standard operating procedures

EDUCATION

2012 — 2014

University of Maryland Global Campus

MS Biotechnology, Specialization in Bioinformatics

2008 — 2010

University of Maryland Global Campus

Bach. of Technical Professional Studies, Biotechnology

2006 — 2009

Frederick Community College

Associate of Applied Sciences, Bioprocessing Technology

2010 — 2011

Hood College

Certificate, Regulatory Compliance

SKILLS

Pharmaceutical IndustrySopFdaBlackboardMicrosoft OfficeRegulatory SubmissionsClinical TrialsAdobe AcrobatNdaIsi ToolboxBiotechnologyChemistryBiochemistryCROPythonLatexMicrobiologyIndTechnology TransferClinical DevelopmentAssay DevelopmentRegulatory AffairsLifesciencesCell CultureXmlMedical DevicesClinical ResearchGcpBiopharmaceuticalsEctdGlpQuality ControlGmp

ABOUT MICHAEL MATTHEWS

Regulatory affairs

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