Regulatory Affairs Manager - International CDx

• You will secure regulatory approvals for products within your area of responsibility by collaborating closely with cross-functional teams across defined markets.
• You will coordinate and compile submission deliverables in a timely manner to ensure all product registrations stay on track with planned timelines.
• You will maintain product licenses throughout their entire life cycle, managing successful Health Authority notifications and submissions in strict accordance with quality management change control processes.
• You will drive the efficiency and success of regulatory strategies by fostering strong partnerships with internal stakeholders and external entities, including Health Authorities and Notified Bodies.
• You will provide strategic regulatory input based on international requirements and directly support global submissions by managing data, addressing Health Authority inquiries, and keeping international affiliates informed of key project updates.
• You will serve as a subject matter expert, ensuring that complex regulatory requirements and strategic goals are clearly communicated, implemented, and kept transparent across the organization.

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.