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La position

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.

As a Regulatory Affairs Specialist you will have the opportunity to work with internal and external teams for project/product realization, write and prepare submission packets for health authority marketing approvals,



and utilize agile principles to drive regulatory activities for our Oncology In-vitro Diagnostics (IVD) team.

Your Opportunity
- Regulatory document and submission compilation: You oversee the development of registration dossiers for moderately complex products or programs. You develop and manage comprehensive general regulatory submissions and registration plans.
- External interface management: You take initiative and partner effectively with stakeholders to understand problems and opportunities to provide best solutions. This includes developing external relationships that significantly influence the present and future direction for Roche and our products. You contribute to audit preparation, execution and follow up.
- Regulatory knowledge and strategy: You develop a good understanding of healthcare regulatory frameworks, such as IVDR. You apply this understanding to create a regulatory strategy to legally market Roche product

📌 Regulatory Affairs Specialist (San Cugat del Vallés)
🏢 Roche Holding
📍 San Cugat del Vallés