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Michele T. Location
Charlotte, NC, US
Michele T. Work
Lead, Global Regulatory Labeling and Ad Promo @ (September 2026 - Present)
Associate Director, Regulatory Labeling @ (July 2026 - September 2026)
Associate Director, Labeling Operations and Compliance @ (November 2021 - July 2026)
Regulatory Labeling Manager @ (October 2019 - November 2021)
Principal Specialist, Regulatory Drug Project Delivery @ (September 2018 - October 2019)
Michele T. Education
UC Irvine
Bachelor's Degree (English)
1997-2002
Michele T. Skills
Adobe Creative Suite
BLA
Biotechnology
CAPA
CSS
Change Control
Collaboration
Compliance Reporting
Continuous Improvement
Corrective and Preventive Action (CAPA)
Creative Thinking
Cross-functional Team Leadership
Deviations
EMA
Electronic Common Technical Document (eCTD)
GMP
Global Labeling
Good Manufacturing Practice (GMP)
GxP
HTML
HealthCanada
Illustrator
InDesign
MAA
Microsoft Excel
Microsoft Office
Microsoft PowerPoint
Microsoft Word
NDA
NDC
Packaging Design
Pharmaceutical Industry
Pharmaceutical Packaging
Photoshop
Product Development
Product Launch
Project Management
Quality Assurance
Quality System
RIMS
Regulatory Affairs
Regulatory Labeling
Regulatory Requirements
Regulatory Submissions
Research
Retail Packaging
SOP
SOP Authoring
Social Media
Standard Operating Procedure (SOP)
Strategy
Structured Authoring
U.S. Food and Drug Administration (FDA)
U.S. Title 21 CFR Part 11 Regulation
Validation
Veeva Vault
Visio
WordPress
FDA
Medical Devices
21 CFR Part 11
Clinical Research
Software Documentation
Clinical Trials
u.s. Food and Drug Administration
Standard Operating Procedure
Michele T. Summary
Michele T., based in Charlotte, NC, US, is currently a Lead, Global Regulatory Labeling and Ad Promo at ICON plc. Michele T. brings experience from previous roles at Ultragenyx, Amicus Therapeutics, ICON plc and AstraZeneca. Michele T. holds a 1997 - 2002 Bachelor's Degree in English @ UC Irvine. With a robust skill set that includes Adobe Creative Suite, BLA, Biotechnology, CAPA, CSS and more. Michele T. has 2 emails and 1 mobile phone numbers on RocketReach.
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