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:

• Opportunity to make an impact in a dynamic and multifaceted environment by leveraging global clinical trial regulatory expertise to accelerate patient access to treatments.
• Act as the first point of contact for regulatory clinical trial expertise providing strategic guidance and insights to the organization.
• Serve as a strategic partner by challenging strategies connecting ideas and taking smart risks to drive innovative and forward-thinking solutions.
• Focus on accelerating global clinical studies to support the registration and launch of new products.
• Improve efficiencies by applying cross-study learnings and offering actionable insights into global clinical trial regulations.
• Proactively monitor and interpret regulatory changes to ensure compliance and align internal processes with evolving guidelines.
• Lead global regulatory procedures for clinical study submissions engage with health authorities to secure approvals and help shape the external regulatory environment.
• Emphasize personal and team growth through continuous learning coaching mentoring and contributing to cross-organizational initiatives for process optimization.

Who you are:

• 1-3 years of experience and a bachelors degree with local experience working with at least one health authority.
• Foundational knowledge of EU clinical trial regulations IVDR MDR or other relevant clinical trial and device regulatory requirements outside Europe.
• Familiarity with GCP principles and exposure to tools such as the EU Clinical Trial Information System (CTIS) and Veeva enabling effective support of clinical studies.
• Keen interest in developing regulatory skills through knowledge and hands-on experience.
• Growth-oriented with the ability to assess priorities adapt to dynamic environments and contribute to evolving business and regulatory strategies
• Strong communication and collaboration skills confident working with stakeholders like health authorities and external partners to achieve shared goals

Relocation benefits are not available for this position

Who we are

A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.