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 tomorrows 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 were 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 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 and participate in Data Protection Impact Assessments (DPIAs).

• Impact Strategy & Complexity: Deliver impact extending to specific products initiatives or clusters involving multiple solutions; translate requirements into strategic implementation plans influence tactical decisions and contribute to long-term solution roadmaps.

Who you are:

• Education & Experience: Bachelors degree in Computer Science Information Technology Legal Studies or a related field (Required); 5 years of Business Analysis / Consultancy experience with at least 3 years in life sciences/pharma or the assigned business function (Required).

• Technical & Regulatory Skills: Hands-on experience with 21 CFR Part 11 GxP ALCOA GDPR HIPAA and EU AI Act alongside an awareness of Software as a Medical Device (SaMD) (Required).

• BA Toolkit & Frameworks: Advanced knowledge of BA practices with strong proficiency in requirements elicitation documentation traceability and change management; independent application of frameworks like Business Process Modelling (BPMN) SWOT gap analysis and risk management (Required).

• Systems Tools & Data Literacy: Proficiency with Agile Lifecycle Tools (Jira Confluence Retina) and Diagramming/Mockup Tools (Visio Miro Lucidchart AI prototyping); comfort navigating complex technical architectures data models cloud infrastructure concepts and audit log structures (Required).

• Core Competencies & Certifications: Exceptional communication conflict resolution and consensus-building skills with a systems-thinking mindset and analytical rigor; CBAP certification (or equivalent like IIBA CCBA Six Sigma Green Belt) is preferred and a PMP certification is a plus.

What you get:

• Salary range: 14175.00 - 26325.00 PLN gross based on the employment contract.

• Annual bonus 15% payment based on your performance.

• Dedicated training budget (training certifications conferences diversified career paths etc.).

• Recharge Fridays (2 Fridays off per quarter available).

• Take time Program (up to 3 months of leave to use for any purpose).

• Vacation subsidy available.

• Flex Location (possibility to perform our work from different places in the world for a certain period of time).

• Take Time for Charity (additional paid leave of maximum 2 weeks to engage in the charity action of your choice).

• Private healthcare (LuxMed packages) group life insurance (UNUM) and Multisport.

• Stock share purchase

Apply directly and join us in shaping the future of healthcare.

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Polska sp. z o.o. operates in full compliance with the law and does not tolerate any violations. Roche Polska sp. z o.o. has implemented a Procedure for Reporting Violations of Law. If you wish to report any irregularities related to our activities all necessary information regarding the reporting process can be found on our website: & BenefitsThe expected salary range for this position based on the primary location of Warsaw Grafit is 170100.00 PLN - 315900.00 PLN. Final compensation will be determined by a number of factors including your skills experience qualifications and addition to base pay this role may be eligible for a discretionary annual bonus with a target of 15% subject to both individual and company performance.

This position also offers an attractive benefits package.

Learn more about how we reward our employees at Roche.

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.