Regulatory Affairs Specialist - Belgian Dutch (Remote)

Worldwide Clinical Trials; Netherlands; Remote; EUR 55,000 - 90,000; Full time

Job summary

Worldwide Clinical Trials is seeking a Regulatory Affairs Specialist to support regulatory submissions across Belgium, France, and the Netherlands. You will work with cross-functional teams to ensure timely submissions, maintain regulatory intelligence, and navigate evolving regulatory landscapes.

The role requires a Bachelor’s in a relevant field, 1+ year of regulatory experience, and fluency in English with Belgian Dutch.

Qualifications

• Bachelor's degree in a medical, biological, physical, health, pharmacy, or related science.
• Minimum of one year of clinical research experience in regulatory affairs or related function.
• Knowledge of ICH GCP, EU Clinical Trials Directive, and applicable regulations.
• Excellent written and verbal communication; ability to collaborate across teams.

Responsibilities

• Coordinate regulatory submissions, ensuring documents are planned, compiled, tracked, and submitted on time.
• Communicate submission status, risks, mitigation plans, and regulatory updates to project teams.
• Review country-specific submission materials, including informed consent forms and patient information.
• Perform quality reviews of regulatory dossiers for accuracy and compliance.
• Maintain regulatory intelligence, country-specific requirements, labeling information, and databases.
• Monitor changes in legislation, providing timely updates and recommendations.
• Advise study teams on regulatory strategy and interpretation of regulations.
• Build relationships with internal and external stakeholders to support reviews and approvals.
• Contribute to training and knowledge sharing to promote quality and excellence.

Skills

Regulatory submissions coordination

Regulatory intelligence

Project management

Written and verbal communication

English proficiency

Belgian Dutch fluency

Education

Bachelor’s degree in a medical/biological/health/pharmacy or related scientific discipline

Tools

Microsoft Word

Excel

PowerPoint

Job description

Worldwide Clinical Trials is seeking a Regulatory Affairs Specialist to support regulatory submissions across Belgium, France, and the Netherlands. You will work with cross-functional teams to ensure timely submissions, maintain regulatory intelligence, and navigate evolving regulatory landscapes.

The role requires a Bachelor’s in a relevant field, 1+ year of regulatory experience, and fluency in English with Belgian Dutch.