Regulatory Affairs Intern

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 **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. 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.