About the job

Our Team

Join our dynamic team as a full-time Regulatory Affairs (RA) Manager in the Netherlands Dutch team!

Under the guidance of Layla Fitoury, our Head of Regulatory Affairs NL, you'll take charge of steering Regulatory Affairs initiatives for our portfolio in the Netherlands and Belgium. As our RA Manager, you'll serve as the local bridge between National Health Authorities, our corporate headquarters, and various internal stakeholders, ensuring seamless collaboration on a wide array of Regulatory matters. Plus, you'll play an essential role in the promotional review process, putting your expertise to work in shaping the future of our brand. You will have the responsibility for your own product portfolio, but with the support you need from the local regulatory team and your RA colleagues in the North European affiliates.

• Obtain and maintain registrations in The Netherlands and Belgium, including all associated Regulatory activities such as process control and lifecycle management.
• Contribute to the regulatory strategy and keep track of applicable national and European law/legislation.
• Ensure Labeling compliance of the portfolio in accordance with Sanofi procedures and law/legislation.
• Coordinate and implement Risk Management activities in accordance with Sanofi procedures and law/legislation.
• Ensure Industrial compliance of packaging components in accordance with Sanofi procedures and law/legislation.
• Contribute to Planning and reporting in dedicated systems.
• Build and lead Health Authority Interactions as interface between the company and Regulatory Agencies.
• Provide Regulatory input to Portfolio Optimization to contribute to company strategies.
• Perform review and approval of Promotional materials to ensure compliance to Sanofi Procedures and current law/legislation.

• Master's degree in medical, pharmaceutical, or biomedical sciences
• Clinical
• Comprehensive knowledge and operational expertise of the EU regulations
• Networking: Building relationships and networks that are useful in achieving objectives. Using informal networks effectively to get things done
• Problem analysis: Identifying issues; recognizing important information; linking data. Tracing potential causes of problems; searching for appropriate data
• Verbal communication: Make ideas and opinions clear to others using clear language, gestures and non-verbal communication. Customize language and terminology to others
• Independence: Taking actions that are based more on one's own convictions than on a desire to please another. Sets his/her own course
• Stress resistance: Continue to perform effectively under time pressure, in the face of setbacks, disappointment or opposition
• Planning and organizing: Effectively setting goals and priorities and identifying time, actions and resources needed to achieve certain goals
• Language: native Dutch speaker and fluent English