Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.

Die 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 integral 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 products and programs of simple-to-moderate regulatory complexity.
- Stakeholder management and influencing: You understand the organizational relationships, key roles, needs, and responsibilities of stakeholders and apply effective stakeholder management. You build effective and enduring relationships with stakeholders and communicate timely and effectively.
- Decision making/Innovation and problem solving: You work with minimal supervision to correctly complete daily activities, which includes presenting both issues and solutions. You drive innovation within one’s own area of influence, and generate consistently new ideas. This includes leveraging unique talents and viewpoints of others.
- VAAC Leadership and agility: You develop the skill to live the spirit of “we all lead” and identify opportunities to develop VACC competency. You act with integrity, courage, passion, and honors commitments.



This includes contributing to an inclusive environment which supports all dimensions of diversity and are open-minded to new technology/other means to increase productivity.
- Teamwork and communication: You establish strong collaborative relationships, share information, knowledge, and guidance readily.You recognize potential conflicts and actively participate in conflict resolution. You are open to the input of others and are truthful regardless of the circumstances.

Who You Are

- You have a Bachelor’s or Master's degree in Life Science, Data Science or related subject. Equivalent experience will be considered.
- You have 1+ years experience, in Regulatory, R, Quality and/or Clinical
- You have experience in Healthcare Regulatory Affairs for IVD/Medical Device preferred.
- You can manage high complexity work and/or global projects, or equivalent experience.

Wer wir sind

Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.

Gemeinsam können wir eine gesündere Zukunft gestalten.

Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.

📌 Regulatory Affairs Specialist (España)
🏢 Roche
📍 España