Regulatory Affairs Intern

F. Hoffmann-La Roche AG; Sant Cugat del Vallès; Presencial; EUR 11.000 - 16.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexible working arrangements

Mentorship and guidance

Hands-on AI projects in regulated env.

Descripción de la vacante

Roche is seeking an intern for Global Regulatory Affairs to support regulatory and product care activities and gain insights into IVD/MD regulations.

You will contribute to AI-powered tools and dashboards, collaborating across affiliates and teams. Open to recent graduates in relevant fields, with English fluency and strong communication skills, in a multinational setting.

Formación

• Recent graduate in biology/life sciences/engineering/data science
• Fluent in English (written and spoken)
• Strong communication and collaboration in multicultural teams
• Familiar with AI tools and prompt engineering
• Curious with detail-oriented problem solving

Responsabilidades

• Assist in worldwide registrations and activities for IVD/MD products
• Support preparation and maintenance of global documentation
• Collaborate with regulatory teams and local affiliates on registrational activities
• Coordinate with global project teams to provide regulatory input
• Support non-registrational regulatory activities
• Assist in designing and testing AI-powered regulatory tools and dashboards
• Participate in training and fine-tuning AI tools for regulatory use
• Stay updated on AI technologies and regulatory guidelines

Conocimientos

English fluency

AI tools familiarity

Team collaboration

Educación

Recent graduate in Biology/Life Sciences/Engineering/Data Science

Herramientas

AI Tools

Descripción del empleo

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

We are looking for a creative, innovative and open-minded intern to join the Global Regulatory Affairs team. As an Intern in Regulatory Affairs, you have the opportunity to support regulatory and product care activities, and get insights into the IVD/MD industry and the applicable regulations and standards for IVD/MD products. In Global Regulatory Affairs we work on specific challenges as a team within all areas of the diagnostic business around the globe, to grow together and to bring the best products to patients while building together a work environment that fits our life. As AI plays an increasing role in our daily lives we are also looking for colleagues who are keen in taking part in high-impact projects that leverage AI Tools to optimize how we navigate the complex landscape of global health regulations. In this intern role, you can clearly demonstrate your creativity and leave a footprint in our products’ lifecycle. You will directly contribute to Roche Diagnostics' vision: innovating diagnostics, shaping healthcare & changing lives.

Your key responsibilities

After your onboarding program, you will be assigned to tasks or projects. You’ll be mostly spending your time in:

• Assisting in the worldwide registrations and activities for various IVD/MD products, at various stages of their development and lifecycle
• Supporting the preparation and maintenance of global documentation for our IVD/MD products
• Collaborating with other regulatory affairs teams, including local affiliates, for registrational activities
• Coordinating with global interdisciplinary project teams to provide regulatory input to development, submission planning, and documentation needed
• Supporting the global regulatory affairs team members in their non-registrational activities
• Assisting in the design, development, and testing of AI-powered tools and dashboards for regulatory tracking, document analysis, and automated reporting.
• Participating in the training and fine-tuning of AI Tools tailored for regulatory use cases, ensuring high accuracy and compliance with internal standards.
• Keep abreast of emerging AI technologies and changing regulatory guidelines regarding AI in the healthcare and pharmaceutical industries.

Who you are

• You have recently graduated (within the last 3 years) in the field of Biology, Life Sciences, Engineering or Data Science
• You are fluent in English (written and spoken)
• You possess facilitation and communications skills and the ability to deal with adversity in a multicultural and international environment
• You are a fast learner, have a proactive attitude to drive solutions, and have a high level of team orientation
• You are curious and attentive to detail with a strong problem-solving capability
• You have Familiarity with AI tools and prompt engineering

What do we offer

• Immerse yourself in the dynamic environment of the world’s leading biotech company, gaining hands‑on experience with cutting‑edge industry practices and shaping the future of global healthcare.
• Become a Regulatory Affairs professional for IVDs/MDs.
• Develop a Regulatory Mindset and understand the most important regulations and industry standards.
• Obtain a unique view of end‑to‑end IVD/MD development and other functions involved.
• Exposure to other functions and networks within the organization.
• Gain experience in a fast‑paced, technological and international environment.
• Lots of learning and a great team to mentor and guide you.
• Hands‑on experience with real‑world AI applications in a highly regulated environment.
• Flexible working arrangements and a collaborative team culture.
• The duration of the internship is 12 months.

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. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.