Clinical Regulatory & Safety Officer

In this role, you will support our Regulatory team with general regulatory activities, maintaining regulatory intelligence, and assisting with submissions for (inter)national (multi-centre) clinical trials. Additionally, you will collaborate with the Medical and Safety team to support clinical safety activities for assigned projects.

• Maintain an intelligence database with (inter)national clinical legislation, requirements, and timelines.
• Assist in organizing general regulatory and medical & safety activities.
• Prepare trackers, systems, tools, and documentation for both teams.
• Manage filing and archiving of documents.
• Support tracking and planning activities to aid vendor management.
• Assist the Medical and Safety team with clinical safety reports and documents, such as SAE listings and MM reports.
• Collaborate with the Quality, Training, and Compliance department to ensure procedures, documentation, systems, and tracking tools are in place.
• Prepare submission packages for reviewing bodies in the Netherlands, Belgium, Ireland, and the United Kingdom.
• Organize meetings and ensure smooth communication within the teams.
• Conduct quality control activities to ensure high standards in the clinical trial submission process.

• A higher level of education, preferably in an administrative or biomedical field.
• Experience handling complex administration and digital data processing.
• Knowledge of EU Clinical Trial Regulation, ICH guidelines, and (inter)national submission regulations.
• Experience in (inter)national communication with reviewing bodies.
• Practical knowledge of medical terminology.
• Proficiency in Microsoft Office.
• Strong command of written and spoken English.
• A minimum of 3 years’ experience in a similar position.

• A collaborative and professional work environment.
• Opportunities for professional development and growth.
• A beautiful office location near Slot Zeist, easily accessible by public transport.
• Flexible working arrangements, with options to work from home, in the office, or a combination of both.

If you are interested in this role, please send your CV and motivation letter to vacancies@juliusclinical.com.

Questions?
For further inquiries, feel free to contact Ellen Hunink, HR Business Partner, at +31 621162980.