Roche Digital Technology (RDT) is seeking a Senior Regulatory Business Analyst for a hybrid role based in Poland. The position sits at the intersection of science, regulation, and technology, translating dense regulatory frameworks into concrete engineering requirements and embedding compliance into every platform we build.

The opportunity: Independently manage end-to-end business analysis workstreams, mentor junior/intermediate BAs, and drive root-cause analysis to deliver clear requirements. Facilitate alignment across Legal, Quality Assurance, Software Engineering, and Validation to establish unified compliance goals. Map and evaluate multi-modal R&D workflows (As-Is vs To-Be) and translate the failure modes of automated pipelines into business impact assessments. Evaluate platforms against 21 CFR Part 11 and GxP standards, applying ALCOA+ principles to current and future data lifecycles, while conducting gap analyses on internal and third-party software.

Roche Digital Technology (RDT) is seeking a Senior Regulatory Business Analyst for a hybrid role based in Poland. The position sits at the intersection of science, regulation, and technology, translating dense regulatory frameworks into concrete engineering requirements and embedding compliance into every platform we build.

The opportunity: Independently manage end-to-end business analysis workstreams, mentor junior/intermediate BAs, and drive root-cause analysis to deliver clear requirements. Facilitate alignment across Legal, Quality Assurance, Software Engineering, and Validation to establish unified compliance goals. Map and evaluate multi-modal R&D workflows (As-Is vs To-Be) and translate the failure modes of automated pipelines into business impact assessments. Evaluate platforms against 21 CFR Part 11 and GxP standards, applying ALCOA+ principles to current and future data lifecycles, while conducting gap analyses on internal and third-party software.