Manager Regulatory Affairs @ (April 2018 - March 2021)
Regulatory Affairs Specialist @ (April 2014 - April 2018)
Clinical Information Specialist @ (January 2012 - January 2013)
Documentation Specialist @ (January 2009 - January 2012)
Cryptologic Technician @ (January 1999 - January 2009)
Beth Stofka Education
The Johns Hopkins University
Master of Science (MS) (Regulatory Science)
2012-2013
University of West Florida
Bachelor of Science (BS) (Health Services/Allied Health/Health Sciences, General)
2006-2009
Beth Stofka Skills
Biotechnology
CRO
Clinical Data Management
Clinical Development
Clinical Monitoring
Clinical Research
Clinical Trials
Communication
Compliance
Delegation
FDA
GCP
Global Regulatory Compliance
Human Subjects Research
ICH-GCP
INDs
Internal Audit
Medical Devices
Military Experience
Oncology
Peer Mentoring
Peer Reviews
Performance Improvement
Pharmaceutical Industry
Process Improvement
Project Planning
Public Health
Regulatory Affairs
Regulatory Documentation
Regulatory Submissions
Team Leadership
Team Management
Technical Analysis
Training
U.S. Food and Drug Administration (FDA)
Veterans
Beth Stofka Summary
Beth Stofka, based in Carlsbad, CA, US, is currently a Director, Regulatory Affairs at GenMark Diagnostics. Beth Stofka brings experience from previous roles at GenMark Diagnostics, Thermo Fisher Scientific (Life Technologies) and The EMMES Corporation. Beth Stofka holds a 2012 - 2013 Master of Science (MS) in Regulatory Science @ The Johns Hopkins University. With a robust skill set that includes Biotechnology, CRO, Clinical Data Management, Clinical Development, Clinical Monitoring and more. Beth Stofka has 4 emails and 2 mobile phone numbers on RocketReach.
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