Gloria Lee Email & Phone Number

Vice President, Global Regulatory Affairs and Quality @ Veracyte, Inc.

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Gloria Lee Location

Toronto, ON, CA

Gloria Lee Work

2024 -now Vice President, Global Regulatory Affairs and Quality @
2023 -now Adjunct Faculty and Masters in Science, Regulatory Affairs Program @
2019 -2024 Senior Director, Head of Regulatory Affairs @
2022 -2022 Regulatory Affairs Mentor @
2015 -2019 Director, Head of Regulatory Affairs and Quality @
2018 -2018 Invited Speaker - Association of Medical Diagnostics Manufacturers 45th Meeting @ Association of Medical Diagnostics Manufacturers AMDM
2014 -2015 Director, Head of Clinical, Regulatory and Quality (Management Team) @ Xagenic Inc.
2013 -2014 Director, Head of Regulatory Affairs and Quality Assurance (US Management Team) @
2011 -2013 Regulatory Affairs Program Manager @
2008 -2010 Regulatory Affairs Manager (Global Submissions) @
2006 -2008 Senior Regulatory Affairs Associate @
1998 -1999 Regulatory Affairs Associate @ SmithKline Beecham Corporation
1997 -1997 Medical Information Associate @

Gloria Lee Education

University of Toronto
Ph.D. (Pharmaceutical Sciences, Neuropharmacology (Drug transport in brain))
1999-2006
McMaster University
B.Sc. (Biology and Pharmacology )
1994-1999

Gloria Lee Skills

In Vitro Diagnostic regulations for US FDA, Health Canada, and European Union
Preparation of regulatory submission dossiers
US FDA electronic submission program (CeSub) for premarket device applications
Negotiations with regulatory authorities in pre- and post-market phases
Participation in ISO 13485 audits
People management and leadership (direct and indirect)
Verbal and written communication (including public speaking)
Execution of multiple projects with tight timelines
Scientific writing (peer reviewed publications and reviews)
Regulatory writing (dossiers, formal correspondences, product inserts)
Use of document management control systems (Qumas, Agile)
Computer (word, excel, powerpoint)
Editorial (review of labeling materials to be compliant with regulations)
Preparation of Canadian drug submissions (IND, NDS, S/NDS)
Preparation of Investigational Trial Applications to Health Canada
Clinical Trial Registrations with Authorized Reps in the EU
Working within Quality System Regulations (ISO 13485:2003 and 21 CFR 820 QSRs)
Participation in US FDA inspection (21 CFR 820)
FDA
Lifesciences
ISO 13485
Validation
Regulatory Affairs
Quality System
Quality Assurance
Medical Devices
Mass Spectrometry
Regulatory Submissions
Assay Development
Clinical Trials
Pharmaceutical Industry
Regulatory Requirements
Cross-functional Team Leadership
Clinical Development
In Vitro
Life Sciences
Participation In Us Fda Inspection 21 Cfr 820
Editorial Review Of Labeling Materials To Be Compliant With Regulations
Leadership
Negotiations With Regulatory Authorities In Pre And Post Market Phases
PowerPoint
Agile
Molecular Diagnostics
In Vitro Diagnostic Regulations For Us Fda
Formal Correspondences
Applications
Regulatory
Business Analysis
Excel
Preparation Of Canadian Drug Submissions Ind
Health Canada
European Union
2003 And 21 Cfr 820 Qsrs
S/Nds
Working Within Quality System Regulations Iso 13485
Use Of Document Management Control Systems Qumas
Marketing
Verbal And Written Communication Including Public Speaking
Cross Functional Team Leadership
Computer
Nds
Regulatory Writing Dossiers
Word
People Management And Leadership Direct And Indirect
IVD
Product Inserts
Scientific Writing Peer Reviewed Publications And Reviews
Us Fda Electronic Submission Program for Premarket Device Applications
People Management and Leadership
Verbal and Written Communication
Scientific Writing
Regulatory Writing
Use of Document Management Control Systems
Editorial
Preparation of Canadian Drug Submissions
Working Within Quality System Regulations
Participation in Us Fda Inspection

Gloria Lee Summary

Gloria Lee, based in Toronto, ON, CA, is currently a Vice President, Global Regulatory Affairs and Quality at Veracyte, Inc.. Gloria Lee brings experience from previous roles at Northeastern University, Helix and Nucleate Bay Area. Gloria Lee holds a 1999 - 2006 Ph.D. in Pharmaceutical Sciences, Neuropharmacology (Drug transport in brain) @ University of Toronto. With a robust skill set that includes In Vitro Diagnostic regulations for US FDA, Health Canada, and European Union, Preparation of regulatory submission dossiers, US FDA electronic submission program (CeSub) for premarket device applications, Negotiations with regulatory authorities in pre- and post-market phases, Participation in ISO 13485 audits and more. Gloria Lee has 3 emails on RocketReach.