Regulatory Project Manager

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

This role sits within our Regulatory Affairs division. We operate with a holistic approach to project and product realization, ensuring that we maintain strict compliance while continuously accelerating innovation for our customers and patients.

The Opportunity

As a Regulatory Affairs Project Manager, your day-to-day focus will center on managing stakeholders, navigating complex compliance pathways, and driving product approvals. Your core responsibilities will be distributed across the following key areas:

• Regulatory Submissions : Oversee the development of medium-to-high complexity submission and product registration dossiers; apply a deep understanding of global healthcare regulatory frameworks to secure marketing approvals from health authorities.

• Teamwork & Collaboration: Pull cross-functional groups together around common goals, build on different perspectives to enhance project outcomes, and resolve conflicts by creating an atmosphere of openness and trust.

• Stakeholder Management: Effectively communicate and partner with internal and external teams to understand requirements and deliver optimal solutions, developing relationships that significantly influence the future direction of Roche products.

• Communication & Agile Frameworks: Use agile principles to drive regulatory activities. Foster an open exchange of ideas amongst key stakeholders to shift perspectives, reach common outcomes, and reflect multiple viewpoints on complex issues.

• Decision Making & Leadership: Work day-to-day with minimal guidance to correctly execute scheduled and unscheduled activities. Live the spirit of "We all lead" using VACC principles, persuading and supporting colleagues over whom you have no direct authority.

• Problem Solving & Agile Mindset: Independently troubleshoot operational issues, develop cost-effective solutions to maintain compliance, and actively simplify processes to increase productivity across Q&R.

Who you are

• You hold a Bachelor's or Master's degree in Life Science, Data Science, or a related subject (or possess equivalent qualification/completed training as a laboratory technician).

• You bring at least 5 years of professional experience (5–10 years preferred) working within Regulatory, R&D, Quality, Operations, and/or Clinical environments.

• You have a proven track record handling healthcare regulatory affairs and can confidently manage high-complexity work or global projects.

• You are capable of working independently with minimal supervision, taking the initiative to generate new ideas, try fresh approaches, and present well-formulated solutions.

• You possess strong communication and social competencies, with the ability to navigate direct, open discussions and guide diverse viewpoints to a unified direction.

• You are willing and able to accommodate business travel as required by project demands.

Preferred

• Familiarity and experience with FDA IVD regulations and EU IVDR regulations highly preferred.

Relocation benefits are not available for this 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.