System Owner (m/f/d) RIMS & eCTD
Fresenius Kabi(3 months ago)
About this role
The System Owner will oversee the global Regulatory Information Management System (RIMS) and eCTD platforms, managing their full lifecycle from implementation through continuous improvement. The role ensures systems meet regulatory standards (e.g., GxP, 21 CFR Part 11, EU Annex 11) and support electronic marketing authorization submissions worldwide.
Required Skills
- System Ownership
- eCTD
- RIMS
- Regulatory Submissions
- GxP
- CSV
- Validation
- Data Quality
- Documentation
- Veeva
+4 more
Qualifications
- Degree in Life Sciences
- Degree in Computer Science
About Fresenius Kabi
fresenius-kabi.comA global player in the world of healthcare: Fresenius Kabi! ▶ Learn more about our different expertise fields ✓ responsibilites ✓ career opportunities ✓
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