Regulatory Affairs Specialist — Belgian Dutch (Remote)

Worldwide; Brussel Hoofdstad; Hybride; EUR 42 000 - 62 000; Plein temps

Résumé du poste

Worldwide Clinical Trials is seeking a Regulatory Affairs Specialist fluent in Belgian Dutch to support regulatory submissions across Belgium, France, and the Netherlands. You will work with cross-functional teams to ensure timely delivery of regulatory documents while maintaining compliance with local and global standards.

The role requires a bachelor’s degree in a related scientific field and at least one year of clinical research experience in regulatory affairs or site activation.

Qualifications

• Bachelor's degree in a medical, biological, physical, health, pharmacy or related scientific discipline.
• Minimum of one year of clinical research experience, preferably in regulatory affairs or site activation.
• Working knowledge of ICH GCP, EU Clinical Trials Directive, and other regulatory guidance.
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint).
• Fluency in English; Belgian Dutch is a plus.

Responsabilités

• Coordinate regulatory submissions, ensuring documents are planned, compiled, tracked, and submitted within required timelines.
• Review and support country-specific submission materials, including informed consent forms and patient information documents.
• Maintain regulatory intelligence, country-specific requirements, labeling information, and regulatory databases.
• Advise study teams on regulatory strategy and interpretation of regulations and directives.
• Build strong relationships with internal and external stakeholders to support efficient review and approvals.

Connaissances

Regulatory submissions

Regulatory strategy

Project management

Cross-functional collaboration

English communication

Dutch fluency

Formation

Bachelor's degree in a related scientific discipline

Outils

Microsoft Office

Description du poste

Worldwide Clinical Trials is seeking a Regulatory Affairs Specialist fluent in Belgian Dutch to support regulatory submissions across Belgium, France, and the Netherlands. You will work with cross-functional teams to ensure timely delivery of regulatory documents while maintaining compliance with local and global standards.

The role requires a bachelor’s degree in a related scientific field and at least one year of clinical research experience in regulatory affairs or site activation.