• Location: Prague, Czech Republic
• Employment Type: Part-time (80 hours/month), Fixed-term , 12 months contract
• Hybrid
• Start Date: As soon as possible

About the job

As a Regulatory Affairs Trainee within our Regulatory Affairs team in the Czech Republic, you'll gain hands-on experience in pharmaceutical regulatory processes while supporting critical documentation and compliance activities. Ready to get started?

Join a team where you'll develop practical regulatory expertise while contributing to meaningful work that helps bring life-changing treatments to patients. This is an excellent opportunity for students passionate about pharmaceutical science to build a strong foundation in regulatory affairs and gain exposure to real-world processes in a global biopharma environment.

About Sanofi

We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.

Main responsibilities

• Prepare and manage regulatory documentation for registration change applications using the Vault RIM system, working with company files, base packages, and associated folders.

• Maintain accurate database records in the Registration Tracking module, supporting planning, tracking, and reporting of regulatory events by product and country.

• Translate regulatory documents between English and Czech, ensuring accuracy of medical and pharmaceutical terminology and consistency across all materials.

• Support archiving of regulatory department documentation within the Vault RIM system, following proper protocols and retention policies.

• Develop your regulatory knowledge by studying Czech and European legislation, including Identification of Medicinal Products (IDMP) requirements and relevant guidelines.

• Provide assistance on departmental projects and market access initiatives, supplying regulatory data as needed for various stakeholders.

About you

• Education: Currently enrolled as a student in Medicine, Pharmacy, Public Health, Biology, or Chemistry

• Interest & Attitude: Genuine interest in pharmaceutical regulatory affairs and pharmaceutical law, with an engaged, proactive, and systematic approach to work

• Language Skills: Very good command of English (including medical terminology) and Czech language proficiency

• Technical Skills: Advanced proficiency in MS Office applications and ability to quickly learn new software systems and databases

• Personal Qualities: Strong communication skills, detail-oriented with high level of accuracy, and methodical approach to tasks

• Experience: Previous experience in the pharmaceutical industry is an advantage but not required

Why choose us?

• Launch your regulatory career with structured learning in a real-world pharmaceutical environment, gaining practical experience with industry-standard systems and processes.

• Develop specialized expertise in regulatory affairs, building knowledge of Czech and European legislation, IDMP requirements, and pharmaceutical compliance.

• Work with cutting-edge technology, including the Vault RIM regulatory information management system used across the global pharmaceutical industry.

• Gain cross-functional exposure by collaborating with experienced regulatory professionals and supporting projects that connect to market access and product launches.

• Build your professional network within a global biopharma leader, opening doors for future career opportunities in regulatory affairs.

• Enjoy flexible part-time hours (80 hours/month) designed to complement your studies while providing meaningful professional experience.

• Contribute to meaningful work that helps ensure patients receive safe, effective treatments through proper regulatory compliance and documentation.

#LI-EUR

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Pursue Progress. Discover Extraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

Watch 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com