Senior Regulatory Business Analyst

Job 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, 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: Bachelor’s 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: 14,175.00 - 26,325.00 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. If you feel this offer suits a friend of yours, feel free to share it. Want to know what it’s like to be a part of Roche IT first-hand? Check out our blog! https://careers.roche.com/global/en/we-are-roche ….. The controller of your personal data is Roche Polska Sp. z o.o., ul. Domaniewska 28, 02-672 Warsaw. The data is processed for the purpose of recruitment. You have the right to access your data, rectify it, delete it, limit processing, transfer it and - if processing is based on your consent - withdraw this consent at any time. Contact the Data Protection Officer at: Ochrona.danych@roche.com. More information on the principles of processing your personal data by Roche at the link: https://www.roche.pl/pl/content/klauzula-informacyjna-rekrutacja-en.html Roche 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: https://www.roche.pl/kontakt/ochrona-sygnalistow-zglaszanie-naruszen. Compensation & BenefitsThe expected salary range for this position, based on the primary location of Warsaw Grafit is 170’100.00 PLN - 315’900.00 PLN. Final compensation will be determined by a number of factors, including your skills, experience, qualifications, and location. In addition to base pay, this rol