Regulatory Affairs Intern– Rare Diseases

Sanofi; Amsterdam; Hybrid; EUR 13.000 - 18.000; Teilzeit

Zusammenfassung

Sanofi is seeking a Regulatory Affairs Intern in Amsterdam to join its Global Regulatory Affairs team. You will support regulatory activities for medicines in Rare Diseases and Rare Blood Disorders, including submissions and interactions with authorities.

You will learn through hands-on experience, mentored by regulatory professionals, and contribute to projects that bring innovative therapies to patients worldwide.

Qualifikationen

• Pursuing a Master's degree or equivalent in Pharmacy or Regulatory Affairs with a 6-month internship.
• Strong organisational and analytical abilities with attention to detail.
• Ability to work effectively in an international environment and in a team.

Aufgaben

• Support research and interpretation of regulatory guidelines for medicines in development and marketed products.
• Assist with preparation, coordination and submission of regulatory documents (e.g., orphan designation, pediatric plans, CTAs).
• Contribute to the preparation of scientific advice requests and regulatory responses to health authorities.
• Assist interactions with European and US health authorities and review regulatory feedback.
• Participate in regulatory team meetings and collaborate on ongoing projects.
• Monitor changes in regulatory requirements and maintain regulatory databases and tools.

Kenntnisse

Organisational skills

Analytical skills

Teamwork

Communication

Ausbildung

Master's in Pharmacy

Regulatory Affairs

Tools

Microsoft Office

Jobbeschreibung

• Work Model: Hybrid (3 days in office, 2 days working from home)

• Location: Amsterdam
• Start date: February/March 2027
• Duration: 6 months
• Work Model: Hybrid (3 days in office, 2 days working from home)

About The Job

As a Regulatory Affairs Intern, you will join Sanofi's Global Regulatory Affairs team, supporting regulatory activities for medicines in the Rare Diseases and Rare Blood Disorders portfolio, including both marketed products and those in development.

Working alongside experienced regulatory professionals, you will gain hands‑on experience in global regulatory processes, contribute to regulatory submissions, and support activities that help bring innovative treatments to patients worldwide.

Ready to grow your skills while helping shape the future of healthcare? At Sanofi, you’ll be empowered to learn, ask questions, and bring your ideas to life – all while supported by inspiring mentors and collaborative teams.

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

• Support the research and interpretation of regulatory guidelines and requirements for medicines in development and marketed products.
• Assist with the preparation, coordination and submission of regulatory documentation, including orphan drug designation applications, paediatric investigation plans and clinical trial applications.
• Contribute to the preparation of scientific advice requests, regulatory variations and responses to questions from health authorities.
• Support preparation for interactions with European and US health authorities, including reviewing and analysing regulatory feedback.
• Participate in regulatory team meetings and collaborate with colleagues on ongoing projects.
• Help monitor and assess changes in regulatory requirements and legislation that may impact ongoing projects.
• Maintain regulatory databases and tools, ensuring information is accurate, up to date and compliant with relevant requirements.

About You

To excel in this role you will need to have:

• Currently pursuing a Master's degree or equivalent postgraduate qualification in Pharmacy or Regulatory Affairs, with a 6-month internship as part of your studies.
• Initial knowledge or experience in Regulatory Affairs.
• Good command of English, with the ability to communicate effectively in an international environment.
• Good working knowledge of Microsoft Office applications.
• Strong organisational and analytical skills, with attention to detail.
• Ability to work independently, take initiative and adapt to changing priorities.
• Good interpersonal and teamwork skills, with a collaborative approach to working with others.

Why choose us?

• Stretch your skills through apprenticeships, internships, graduate programs, and international experiences that grow with you.
• Learn from inspiring mentors and collaborative teams while contributing to real projects that shape the future of healthcare.
• Build your future with access to the latest tools, digital innovation, and continuous learning that keep you ahead of the curve.
• Grow in a purpose-driven company where your voice matters and your work helps improve millions of lives.
• Thrive in inclusive, flexible workplaces that support your personal and professional well-being.
• Launch your career with a company that invests in you — and empowers you to reimagine what’s possible.

We reserve the right to close this vacancy earlier than the advertised closing date should we receive a sufficient number of applications.