• 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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Toujours Progresser. Découvrir l’Extraordinaire.

Rejoignez Sanofi et entrez dans une nouvelle ère de la science – où votre parcours peut être aussi transformateur que le travail que nous accomplissons. Nous investissons en vous pour que vous alliez plus loin, accélériez votre réflexion et accomplissiez ce qui n’a jamais été fait auparavant. Vous contribuerez à repousser les limites, à bousculer les conventions et à concevoir des solutions plus intelligentes pour les communautés que nous servons. Prêt·e à poursuivre les miracles de la science et à améliorer la vie des gens ? Poursuivons le progrès et découvrons l’extraordinaire – ensemble.

Chez Sanofi, nous croyons dans l’égalité des chances, sans distinction de race, de couleur, d’ascendance, de religion, de sexe, d’origine, d’orientation sexuelle, d’âge, de citoyenneté, d’état civil, de handicap, d’identité de genre ou de tout autre critère protégé par la loi.