Mary Harvey

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.

Experience

1. Labeling Manager, Regulatory Affairs

   Endo

   Jul 2022 — Present

   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

  1999 — 2001

Skills

• Graphic Design
• Quality Control
• Gmp
• Pharmaceutical Industry
• Sop
• Verification and Validation (V&V)
• Fda
• Validation
• Quality System
• V&V
• Creative Direction
• Marketing
• Typography
• Change Control
• Adobe Creative Suite
• Regulatory Affairs
• 21 Cfr Part 11
• Standard Operating Procedure (Sop)
• Technology Transfer
• Packaging
• Photography
• Graphics
• Capa
• Packaging Design
• Pharmaceutics
• U.s. Food and Drug Administration (Fda)
• Manufacturing