Regulatory Affairs Manager

Responsibilities

• Lead regulatory affairs initiatives for the Netherlands and Belgium portfolio, including Rare Diseases and General Medicine franchises
• Act as the primary interface between Sanofi and National Health Authorities to build strong professional relationships
• Obtain and maintain product registrations through optimal process control (NP, MRP/DCP, CP)
• Ensure labeling compliance and coordinate updates for product information and packaging
• Provide strategic regulatory input for product portfolio optimization and registration strategies
• Review and approve promotional and non-promotional materials to ensure compliance with local laws and internal guidelines
• Coordinate the implementation of risk management plans and educational materials

Requirements

• Master’s degree in medical, pharmaceutical, or biomedical sciences
• Comprehensive knowledge and operational expertise of EU regulations
• Native Dutch speaker with fluency in English
• Strong ability to analyze complex problems and link data to identify potential causes
• Proven ability to plan, organize, and prioritize tasks effectively under time pressure
• Openness to leveraging AI tools and digital innovation to enhance regulatory processes

About the Company

Sanofi is a global healthcare leader where deep immunoscience meets cutting-edge innovation. We work across oncology, rare diseases, neurology, and vaccines to turn breakthrough ideas into real-world impact. At Sanofi, we invest in our people to help them reach further and challenge convention, driving scientific breakthroughs that improve lives worldwide.