Jobbeschreibung
We have a clear commitment: putting best-possible solutions in the hands of medical professionals, enabling them to find the right answer to the challenge they face. Fresenius Kabi is a driver of healthcare for the coming decade. We truly live diversity and value different backgrounds and motivations.
#careerswithapurpose at Fresenius
Over 300,000 people across the globe work at Fresenius to provide better ever medicine for ever more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career – and to become part of our impressive growth story.
To strengthen our team in the regulated (GxP) environment, we are looking for a dedicated System Owner for our global Regulatory Information Management System (RIMS) and the Electronic Common Technical Document (eCTD) as soon as possible. These systems are essential for the creation, management and submission of electronic marketing authorization documents in accordance with the eCTD standard.
In this key role, you will assume overall responsibility for the entire life cycle of the systems — from implementation and operation to continuous further development — and ensure that all regulatory requirements (e.g. GxP, 21 CFR Part 11, EU Annex 11) are met.
- Responsible for the functionality, data quality, compliance, and user-friendliness of RIMS and eCTD systems.
- Ensuring the operation, maintenance and further development of the systems (Extedo eCTDmanager, Veeva RIM).
- Ensuring compliance with regulatory requirements (GxP, FDA, EMA, CSV, Data Integrity) and internal guidelines.
- Responsible for organizing and coordinating system validations and revalidations in close collaboration with Quality Assurance and IT departments.
- Creation and maintenance of system documentation (SOPs, work instructions, system descriptions).
- Serve as the main contact for specialist departments (Regulatory Affairs, QA, IT) and external service providers.
- Collaborate with interdisciplinary teams to define requirements and drive system acceptance.
- Manage incidents, changes, releases, and support audits and inspections.
- Degree in life sciences, computer science, or a related discipline
- Extensive experience working in regulated sectors such as Pharma, Biotech, or MedTech
- Strong expertise in eCTD, regulatory submissions, ISO IDMP (Identification of Medicinal Products) standards, and GxP regulations
- Proven system ownership and hands-on experience with Computer System Validation (CSV)
- Familiarity with GAMP 5, 21 CFR Part 11, and EU Annex 11 compliance standards
- Experience managing Regulatory Information Management Systems and eCTD tools (e.g., Veeva, Extedo or other comparable providers)
- Excellent communication and coordination abilities
- Demonstrates a structured, solution-focused, and independent work style, with a strong team orientation