Regulatory Project Manager (IVD/MD or CDx Regulatory)

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.

Relocation benefits are not available for this job posting.

The Opportunity:

• Stakeholder Management & Communication: Effectively collaborate with internal and external stakeholders to understand needs and deliver optimal solutions. Build strong, trust-based relationships that influence current and future direction. Foster open dialogue, encourage diverse perspectives, and align stakeholders toward common outcomes.

• Decision Making, Leadership & Agile Mindset: Operate independently with minimal supervision, developing and presenting solutions while driving innovation within area of influence. Embody the spirit of “We all lead” through VACC principles, work effectively without formal authority, and continuously cultivate an agile mindset to enhance productivity and impact.

• Problem Solving & Team Collaboration: Proactively troubleshoot issues and implement compliant, cost-effective solutions to ensure operational continuity. Address complex challenges by evaluating solution options and executing decisions effectively while fostering collaboration, openness, and trust.

• Regulatory Strategy & Execution: Demonstrate strong understanding of global healthcare regulatory frameworks and compliance requirements. Lead development of medium- to high-complexity regulatory submissions and marketing authorization dossiers, define regulatory strategies for new products, and apply agile principles to accelerate compliant regulatory activities. Includes IVD/MD or CDx regulatory experience, experience as an integral member of project development teams, and International regulatory experience, particularly in APAC region (must-have).

Who you are:

• Education & Technical Background: Bachelor’s or Master’s degree in Life Sciences, Data Science, or a related field; alternatively, completed training as a technician or laboratory technician, or equivalent qualification aligned with role requirements. Advanced degree is considered an advantage.

• Professional Experience: 5–10 years of experience (minimum 5 years) in Regulatory, R&D, Quality, Operations, and/or Clinical environments, including exposure to healthcare regulatory affairs.

• Complexity & Project Scope: Demonstrated ability to manage high-complexity workstreams and/or global projects, ensuring structured execution and cross-functional alignment.

• Regulatory & Cross-Functional Expertise: Strong understanding of healthcare regulatory frameworks and operational processes, with the capability to navigate multidisciplinary environments and support compliance-driven innovation.

Please note: Resumes must be submitted in English, as our interview panel may include participants from outside your local country.

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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.