Job Description
About the role:
The Solution Architect (m/f/d) – Regulatory & Compliance Applications is responsible for the operation, optimization, and continuous evolution of global regulatory IT solutions. The role ensures full alignment with Good Practice (GxP) requirements, regulatory authority expectations (U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), International Council for Harmonisation (ICH)), and business objectives, while driving operational excellence, data integrity, and system reliability across the regulatory application landscape.
Your key responsibilities:
- Serve as the main technical and functional point of contact for regulatory business process owners, providing governance, consultation, and solution direction.
- Design, configure, monitor, and maintain regulatory IT solutions in compliance with global regulatory standards (FDA, EMA, ICH, GxP).
- Lead and support the full application lifecycle, includi...
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