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The opportunity
Are you passionate about contributing to the development and maintenance of pharmaceuticals and health products in the Dutch market? In this role, you’ll have the opportunity to work across all aspects of bringing a medicinal product to market and ensuring it stays compliant with regulatory requirements. You’ll have the chance to deepen your knowledge of Regulatory Affairs while working alongside a team of five seasoned professionals. 
How you’ll spend your day
Draft and review essential product documentation, including Summary of Product Characteristics (SPC) and patient leaflets, for pharmaceuticals, dietary supplements, medical devices and cosmetics in the Dutch market.
Oversee and assign tasks related to product information, ensuring accuracy and compliance throughout the production of packaging materials for the Dutch market.
Collaborate with external manufacturers, internal teams, regulatory authorities, and international representatives to gather and process product information. Maintain strong, professional relationships with all stakeholders.
Support the registration process for products in the Netherlands, ensuring submissions comply with both national and international regulations. You’ll be responsible for compiling, updating, and adjusting registration dossiers as needed.
Provide advice on regulatory matters, including the submission and modification of dossiers. Help develop the optimal approach to ensure regulatory compliance and successful market authorization.
Serve as the point of contact for regulatory authorities and international representatives, providing accurate and timely responses to inquiries while protecting the company’s interests and objectives.