Regulatory Specialist Diagnostics

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

The Opportunity:

As a Regulatory Specialist, you will be responsible for compiling documents and deliverables to support planned product registration timelines. You will maintain product registration throughout a product’s lifecycle by applying successful regulatory change control and ensuring alignment with local and regional registration requirements. You will work independently within guidelines and policies, acting as a resource for colleagues with less experience and providing functional guidance.

Your key responsibilities will include:

• Submission Management: Coordinate and prepare document packages for regulatory submissions, license renewals, and annual registrations for new and mature products.

• Lifecycle Maintenance: Support currently marketed products regarding labeling, manufacturing changes, and technical file maintenance to ensure ongoing compliance with Global Regulatory directives.

• Information Systems: Maintain and create product information and reports within the Regulatory Information Management System and support documentation management workflows.

• Stakeholder Collaboration: Interface with internal stakeholders and external partners (Health Authorities/Notified Bodies) to promote successful registration strategies and answer submission-related inquiries.

• Global Support: Support international regulatory submissions by providing needed data and documents, keeping Affiliates informed of new products, projects, or process changes.

• Compliance & Strategy: Keep abreast of regulatory procedures and changes, recommending strategies for the earliest possible approvals of clinical trials applications and improving tracking/control systems.

Who you are:

You are a proactive professional with strong communication skills, a resolution-oriented mindset, and the ability to manage complex documentation in a regulated environment.

Requirements and Qualifications:

• Education: Bachelor's or Master's degree in Biology, Chemistry, Pharmacy, or related fields.

• Experience: Proven experience in Regulatory, R&D, Quality, Operations, or Clinical teams, specifically including documentation and country registration tasks. Experience with In Vitro Diagnostics (IVD) is a plus.

• Languages: Advanced English proficiency is a requirement.

• Core Competencies: * Proactive with strong self-management capabilities.

• Flexible, adaptable, and a curious "learning enthusiast."

• Process improvement oriented and able to work independently.

Relocation benefits are not available for this job posting.

Who we are

A 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.