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The PositionRoche 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.
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This position also offers an attractive benefits package.
Learn more about how we reward our employees at Roche.
Who we areA healthier future drives us to innovate. Together, more than 100’000 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.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
Skills Required
- Bachelor's degree in Computer Science, Information Technology, Legal Studies, or related field
- 5+ years Business Analysis/Consultancy experience with at least 3+ years in life sciences or related function
- Hands-on experience with 21 CFR Part 11, GxP, ALCOA+, GDPR, HIPAA, and EU AI Act
- Familiarity/awareness of Software as a Medical Device (SaMD)
- Advanced BA practices: requirements elicitation, documentation, traceability, change management, gap analysis, risk management
- Proficiency with Business Process Modelling (BPMN) and frameworks like SWOT and gap analysis
- Proficiency with Agile lifecycle tools (Jira, Confluence, Retina) and diagramming/mockup tools (Visio, Miro, Lucidchart, AI prototyping)
- Ability to navigate complex technical architectures, data models, cloud infrastructure concepts, and audit log structures
- Experience mapping As-Is/To-Be workflows and assessing automated agentic pipeline failure modes and business impacts
- CBAP (or equivalent like IIBA CCBA, Six Sigma Green Belt) preferred; PMP certification a plus
Roche Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Roche and has not been reviewed or approved by Roche.
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Retirement Support — U.S. materials describe a 401(k) with both matching and an additional company contribution, supported by formal plan documents and true‑up features. This structure is positioned as a standout element of the total package, particularly at Genentech.
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Leave & Time Off Breadth — Time‑off provisions include substantial vacation, a year‑end shutdown, and a paid six‑week sabbatical after six years. These elements indicate a recharge‑oriented approach within the U.S. offering.
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Healthcare Strength — Company materials emphasize comprehensive medical, dental, vision, and mental‑health resources alongside well‑being programs. Benefits pages consistently highlight breadth across core health coverage elements.
Roche Insights
What We Do
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry ten years in a row by the Dow Jones Sustainability Indices (DJSI).
