Kristen Harmon
Regulatory Operations Consultant
- Role
- Regulatory Operations Consultant at Jasper Therapeutics
- Location
- Wilmington, NC, US
- LinkedIn followers
- 500 followers
About Kristen Harmon
Global Reg Ops; Regulatory Intelligence, Project Mgmt; Global Submission Planning & Strategy, PublishingeCTD/NeeS submissions (IND/NDA/BLA/MAA/NDS) and Major Efficacy Supplements (NDA/BLA/MAA/NDS) in US, EU and Canada. ROW Core submissions.Proficient in MS Teams, Veeva Vault, SmartSheet, SharePoint, Insight Publisher, Adobe, ISI Toolbox
Experience
Regulatory Operations Consultant
Nov 2023 — Present
Education
University of Phoenix
Bachelor of Applied Science, Business
Skills
- Computer System Validation
- Clinical Development
- Customer Service
- Regulatory Affairs
- 21 Cfr Part 11
- Regulatory Requirements
- Drug Development
- Ectd
- Regulatory Operations
- Training
- Project Management
- Regulatory Submissions
- Pharmaceutical Industry
- Sop
- Fda
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