Remote Regulatory Affairs Specialist – EU

Worldwide Clinical Trials Limited; Belgique; À distance; EUR 60 000 - 90 000; Plein temps

Résumé du poste

Worldwide Clinical Trials Limited seeks a Regulatory Affairs Specialist to support submissions across Belgium, France, and the Netherlands. This remote role partners with global teams to ensure timely, compliant submissions and regulatory intelligence across multiple countries and projects.

The ideal candidate holds a science degree and at least one year in regulatory affairs or site activation, with strong English and Dutch language skills and proficiency in MS Office.

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, site activation, or a related function within pharma/CRO.
• Working knowledge of ICH GCP, EU Clinical Trials Directive, and related regulations.
• Strong organizational, planning, prioritization, and project management skills.
• Excellent written and verbal communication; ability to collaborate across diverse teams.
• Experience reviewing regulatory documentation and supporting submission activities in a compliance-driven environment.
• Proficiency with Microsoft Office applications; comfortable with digital systems.
• Proficiency in English; fluency in Belgian Dutch.

Responsabilités

• Coordinate regulatory submissions, ensuring documents are planned, compiled, tracked, and submitted on time.
• Communicate submission status, risks, mitigation plans, and regulatory updates with project teams.
• Review country-specific submission materials, including informed consent forms and labeling.
• Perform quality reviews of regulatory dossiers for accuracy and completeness.
• Maintain regulatory intelligence, country-specific requirements, and regulatory databases.
• Monitor changes in legislation and guidance; provide updates and recommendations.
• Advise study teams on regulatory strategy and applicable regulations.
• Build relationships with stakeholders to support efficient review and approvals.
• Contribute to training and departmental initiatives promoting quality.

Connaissances

Regulatory submissions coordination

Clinical research experience

ICH GCP knowledge

Regulatory documentation review

English and Dutch language skills

Formation

Bachelor's degree in medical/biological/health/science

Outils

MS Office (Word, Excel, PowerPoint)

Description du poste

Worldwide Clinical Trials Limited seeks a Regulatory Affairs Specialist to support submissions across Belgium, France, and the Netherlands. This remote role partners with global teams to ensure timely, compliant submissions and regulatory intelligence across multiple countries and projects.

The ideal candidate holds a science degree and at least one year in regulatory affairs or site activation, with strong English and Dutch language skills and proficiency in MS Office.