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.