Roche

Regulatory Affairs Intern

Roche  •  Sant Cugat del Vallès, ES (Onsite)  •  17 days ago
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Job Description

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

Purpose of the role:

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 to bring the best products to patients while choosing 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 machine learning (ML), natural language processing (NLP), and large language models (LLMs) 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 ML and NLP models 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, Computer Science, Bioinformatics

  • 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 are fluent in English (written and spoken)

  • You have a strong proficiency in Python and its data science ecosystem (e.g., Pandas, NumPy, Scikit-learn, PyTorch, or TensorFlow).

  • You have Experience with Natural Language Processing (NLP) techniques and frameworks (e.g., Hugging Face, spaCy).

  • You have Familiarity with Large Language Models (LLMs) and prompt engineering.

  • Experience with data visualization tools (e.g., Tableau, PowerBI, or Matplotlib/Seaborn).

What do we offer?

  • 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.

Roche

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry ten years in a row by the Dow Jones Sustainability Indices (DJSI).

For more information, please visit https://careers.roche.com

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Industry
Biotech & Life Sciences
Company Size
10,000+ employees
Headquarters
Switzerland 🇨🇭 , CH
Year Founded
Unknown
Website
roche.com
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