Kezia Thomas

Regulatory Affairs Professional

RAC-certified biopharmaceutical professional with 12 years of diverse regulatory experience, including 7 years specializing in CMC documentation, regulatory submissions, and life cycle management. Successfully authored and reviewed CMC Modules 1, 2, and 3 for FDA, EMA, and global submissions (INDs, CTAs, ANDAs). Proven expertise in regulatory project management, cross-functional collaboration, and...

Experience: 7+ years

Professional Overview

RAC-certified biopharmaceutical professional with 12 years of diverse regulatory experience, including 7 years specializing in CMC documentation, regulatory submissions, and life cycle management. Successfully authored and reviewed CMC Modules 1, 2, and 3 for FDA, EMA, and global submissions (INDs, ...

Core Specializations

Best suited for

• • MedTech companies seeking expert regulatory guidance

Experience signals

• Background: 7+ years of regulatory experience.

Cruxi view

Kezia Thomas offers a valuable blend of regulatory affairs certification (RAC), 7 years of experience in CMC documentation, and expertise in regulatory submissions for FDA, EMA, and global markets. Her experience authoring and reviewing CMC Modules 1, 2, and 3, coupled with her proficiency in electronic document management systems like Veeva Vault RIM, positions her as a highly capable consultant for biopharmaceutical companies navigating complex regulatory landscapes. Her ability to manage multiple projects while maintaining compliance and timely delivery is a significant asset.

This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.