Michael Matthews
Regulatory affairs
- Role
- Director of Regulatory Affairs at Sabin Vaccine Institute
- Location
- Frederick, MD, US
- LinkedIn followers
- 500 followers
Experience
Director of Regulatory Affairs
Nov 2023 — Present · 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
University of Maryland Global Campus
MS Biotechnology, Specialization in Bioinformatics
2012 — 2014
University of Maryland Global Campus
Bach. of Technical Professional Studies, Biotechnology
2008 — 2010
Frederick Community College
Associate of Applied Sciences, Bioprocessing Technology
2006 — 2009
Hood College
Certificate, Regulatory Compliance
2010 — 2011
Skills
- Pharmaceutical Industry
- Sop
- Fda
- Blackboard
- Microsoft Office
- Regulatory Submissions
- Clinical Trials
- Adobe Acrobat
- Nda
- Isi Toolbox
- Biotechnology
- Chemistry
- Biochemistry
- CRO
- Python
- Latex
- Microbiology
- Ind
- Technology Transfer
- Clinical Development
- Assay Development
- Regulatory Affairs
- Lifesciences
- Cell Culture
- Xml
- Medical Devices
- Clinical Research
- Gcp
- Biopharmaceuticals
- Ectd
- Glp
- Quality Control
- Gmp
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