Amanda Toth
Morgantown
Summary
Dynamic regulatory affairs professional with extensive experience at Viatris, specializing in U.S. and EU labeling compliance. Proven track record in ensuring FDA and EMA adherence, while enhancing data accuracy and documentation control. Adept at cross-department collaboration, leveraging strong communication skills to drive successful product labeling initiatives.
Overview
14
14
years of professional experience
Work History
Lead Specialist – Global Regulatory Affairs Labeling
Viatris
04.2022 - Current
- Prepare new and revised product labeling for ANDAs and EU markets.
- Ensure labeling compliance with FDA guidance, CMC documentation, Orange Book, Drugs@FDA, and Agency correspondence.
- Assess Company Core Data Sheets for impact on U.S. Prescribing Information.
- Collaborate across departments and with third parties to meet regulatory and commercial goals.
- Act as Trackwise system superuser.
Regulatory Affairs Labeling Specialist
Mylan / Viatris
10.2018 - 04.2022
- Maintained product applications to ensure up-to-date labeling.
- Created and revised Structured Product Labeling in ALICE system.
- Trackwise and GLAMS AMS superuser and point of contact for system training and issues.
Regulatory Affairs Associate
Mylan
01.2015 - 09.2018
- Maintained labeling components for regulatory filings.
- Ensured consistency with CMC documentation and FDA references.
Trackwise System Coordinator
Mylan
01.2013 - 12.2014
- Liaised between regulatory departments and global sites for document review.
- Led team training sessions on Trackwise, providing daily support.
Quality Support Associate
Mylan
05.2011 - 12.2012
- Managed approvals for internal change controls.
- Compiled and presented monthly global and site quality metrics.
Education
Bachelor of Science -
West Virginia University
Morgantown, WV01.2005
Skills
- US and EU regulatory labeling
- FDA and EMA compliance
- Structured product labeling
- CMC documentation review
- TrackWise superuser
- Data accuracy and documentation control
- Regulatory compliance
- Product labeling and FDA guidance
Affiliations
- Maintain a record of 100% on-time completion rate for all assigned training modules, demonstrating strong commitment to continuous learning and compliance.
- Maintain an exceptional record of on-time regulatory submissions, reflecting great time management and attention to detail.
- Enhance and support a culture of global regulatory compliance.
References
References available upon request.
Timeline
Lead Specialist – Global Regulatory Affairs Labeling
Viatris
04.2022 - Current
Regulatory Affairs Labeling Specialist
Mylan / Viatris
10.2018 - 04.2022
Regulatory Affairs Associate
Mylan
01.2015 - 09.2018
Trackwise System Coordinator
Mylan
01.2013 - 12.2014
Quality Support Associate
Mylan
05.2011 - 12.2012
Bachelor of Science -
West Virginia University
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