Justin Kueper
Senior Manager, Regulatory Operations
- Role
- Senior Manager, Regulatory Operations at Eikon Therapeutics
- Location
- New York, NY, US
- LinkedIn followers
- 500 followers
About Justin Kueper
I have over 18 years experience working on Regulatory submission. In that time I started at an entry level position and worked my way up to Senior Manager. I worked on numerous NDAs, BLAs, MAA and sNDAs. Also I am experienced in daily eCTD submissions.
Experience
Senior Manager, Regulatory Operations
Mar 2025 — Present · Jersey City, NJ, US
Education
Montclair State University
BA, History
2005 — 2006
Skills
- Regulatory Affairs
- Regulatory Operations
- Validation
- Pharmaceutical Industry
- Sop
- Fda
- New Drug Application (Nda)
- Documentum
- Nda
- Regulatory Requirements
- Standard Operating Procedure (Sop)
- Project Management
- Quality Assurance
- Crfs
- Document Management
- Clinical Trials
- Training
- Ectd
- Regulatory Submissions
- 21 Cfr Part 11
- Biotechnology
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