Mary Harvey
Labeling Manager, Regulatory Affairs @Endo
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WORK HISTORY
Labeling Manager, Regulatory Affairs @Endo
Completed/reviewed revised labeling/SPL and supporting documentation for FDA deficiency letters, post-approval labeling updates and Safety Labeling Updates.• Proofed (FDA) compliant package components and labeling for prescription drugs.• Prepared Labeling submissions in Veeva Vault• Conducted Structured Product Labeling Audit to insure up to date and accurate SPLs. • Created Annual Report Labeling Summary
EDUCATION
The University of Alabama in Huntsville
BA, Political Science, Business, Graphic Design
SKILLS
ABOUT MARY HARVEY
Dedicated and focused Regulatory Labeling Professional who excels in fast-paced environment and follows through to achieve project goals. Developed, created, edited, and formatted FDA documents and components while achieving accurate work under tight deadlines.
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