Experteer Overview In this role within Roche Global Regulatory Affairs, you drive regulatory submissions and strategic planning for complex products, with a focus on Companion Diagnostics. You collaborate across functions and with external stakeholders to ensure timely approvals and strong regulatory positioning. You navigate evolving global regulations, shaping strategies to accelerate worldwide access to diagnostics and therapies. You will lead with integrity and foster an inclusive, agile team culture that advances patient access to healthcare.Compensaciones / Ventajas
- Oversee regulatory document and submission compilation for complex products/programs
- Develop and manage parts of global regulatory submissions and registration plans
- Interface with external stakeholders and manage relationships effectively
- Contribute to audits and support readiness activities
- Lead adaptation to evolving regulatory environments and apply strategic thinking to different regions




- Partner with internal/external stakeholders to devise best solutions and influence project direction
- Demonstrate decisive, proactive leadership and accountability
- Foster VAAC leadership, identify opportunities to develop regulatory competency and build inclusive team environmentsResponsabilidades
- Bachelor in Life Science, Data Science or related subject; advanced degree preferred
- 3–5 years of regulatory affairs experience with PhD, 5–7 years with Master, or 6–8 years with Bachelor in IVDs/Medical devices/Pharma/Biopharmaceuticals
- Experience with Daily Management and Continuous Improvement
- Knowledge of European, US, China and other international regulations; ability to implement quality standardsRequisitos principales
- discretionary annual bonus
- salary range provided
- benefits package per policy

📌 Regulatory Affairs Manager, Companion Diagnostics (Barcelona)
🏢 Roche
📍 Barcelona