Senior Regulatory Business Analyst — Roche

Full description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Senior Regulatory Business Analyst

Roche Digital Technology (RDT) is where innovation meets purpose. As a global team at the heart of Roche, we are a community of business-minded technologists committed to help shape tomorrow’s digital future of healthcare. Our mission is to power Roche through cutting-edge digital technologies, harnessing the potential of artificial intelligence, data, and scalable tech innovations. Driven by purpose and passion, we’re building a future where digital is a core strength across all of Roche, enabling smarter ways of working, unlocking human potential, and driving breakthroughs that truly matter for millions of patients around the world.

At Roche, we offer a hybrid work model that combines flexibility with in-person collaboration. For now, we require our employees to be in our offices on average two days per week. The specific office days may vary depending on business needs, such as workshops, conferences, town halls, team meetings, and other collaborative events.

Diagnostics R&D at Roche operates across a complex intersection of science, technology, and regulation, utilizing AI systems, agentic platforms, and multi-modal data pipelines that must simultaneously be innovative and rigorously compliant. We are looking for a Senior Regulatory Business Analyst who can hold both sides of that tension: translating dense regulatory frameworks into concrete engineering requirements, and ensuring that compliance is embedded into every platform we build or onboard to, not bolted on afterwards. In this role, you will independently manage end-to-end business analysis workstreams, tackling complex business problems with emerging ambiguity while acting as a trusted advisor to cross-functional teams.

The opportunity

• Scope / Content Leadership: Independently manage end-to-end business analysis workstreams without guidance, tackling problems with emerging ambiguity, adapting standard frameworks, mentoring junior/intermediate BAs, and proactively shaping team ways of working.
• Accountability & Problem Solving: Lead the analysis of complex business problems, perform thorough domain research, drive root cause analysis, deliver comprehensive requirements, and proactively identify needs-solution discrepancies to propose creative improvements.
• Stakeholder Management & Orchestration: Build reliance across a diverse range of cross-functional stakeholders to act as a trusted advisor; facilitate alignment workshops and risk-review sessions across siloed departments (Legal, Quality Assurance, Software Engineering, Validation) to establish unified compliance goals.
• Process Mapping & Automated Workflow Evaluation: Analyze, document, and map multi-modal R&D workflows (As-Is vs. To-Be); engage with engineering teams to document, understand, and translate the failure modes of automated agentic pipelines into business impact assessments, ensuring business logic and data integrity remain uncompromised.
• Platform & Ecosystem Regulatory Compliance: Evaluate R&D platforms, software tools, and cloud ecosystems 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 platforms.
• Audit Trail Design & Privacy Standards: Define business requirements for robust, immutable system auditing of user actions and automated model executions; partner with Data Protection Officers (DPOs) to evaluate systems against GDPR and HIPAA mandates, an