Regulatory Affairs Specialist - Belgian Dutch speaker (Western Europe)

Join a global Contract Resource Organization (CRO) where innovation meets purpose. At Worldwide Clinical Trials , we're driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life-changing therapies to patients around the world.

With more than 4,000 professionals across the globe, we foster a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact. Whether you're building your career or bringing years of experience, you'll have the opportunity to learn, grow, and help shape the future of clinical research.

Make an Impact as a Regulatory Affairs Specialist at Worldwide

Play a key role in advancing clinical research studies by supporting regulatory submissions across Belgium, France, and the Netherlands. In this position, you'll help ensure submission activities are planned, prepared, tracked, and delivered efficiently while maintaining compliance with local and international regulatory requirements.

Working closely with Site Activation & Regulatory colleagues and cross-functional teams, you'll provide regulatory expertise, navigate evolving regulatory landscapes, and help drive timely approvals. Your contributions will support effective study start-up activities and the successful delivery of clinical research programs.

This is an opportunity to make a meaningful impact through regulatory excellence, collaboration, regulatory intelligence, and a commitment to quality across multiple countries and projects.

Where You'll Work

This is a remote role open to candidates based in Western Europe (Belgium, France, Netherlands). You will collaborate with global teams across multiple time zones .

What You'll Do

- Coordinate regulatory submissions, ensuring documents are planned, compiled, tracked, and submitted within required timelines.

- Partner with project teams and regulatory colleagues to communicate submission status, risks, mitigation plans, and key regulatory updates.

- Review and support country-specific submission materials, including informed consent forms, patient information documents, labels, and other regulatory documentation.

- Perform quality reviews of regulatory dossiers to help ensure accuracy, completeness, and compliance.

- Maintain regulatory intelligence, country-specific requirements, labeling information, and regulatory databases.

- Monitor changes in legislation, regulations, and guidance, providing timely updates and recommendations to stakeholders.

- Advise study teams on regulatory strategy and the interpretation of applicable regulations, guidance, and directives.

- Build strong relationships with internal and external stakeholders to support efficient review and approval processes.

- Contribute to training, knowledge sharing, and departmental initiatives that promote quality and operational excellence.

What You'll Bring

- 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 the pharmaceutical or CRO industry.

- Working knowledge of ICH GCP, the EU Clinical Trials Directive, and other relevant clinical research regulations and guidance.

- Strong organizational, planning, prioritization, and project management skills with the ability to manage multiple priorities effectively.

- Excellent written and verbal communication skills and the ability to collaborate across diverse teams and stakeholders.

- Experience reviewing regulatory documentation and supporting submission activities in a compliance-driven environment.

- Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint, and comfort working with digital systems.

- Proficiency in English required; fluency in Belgian Dutch.

Discover the Difference

We love knowing that someone is going to have a better life because of the work we do.  Discover the Difference at Worldwide Clinical Trials. Explore additional opportunities on our careers page, visit http://www.worldwide.com/careers , or connect with us on LinkedIn .