Regulatory Affairs Specialist

Regulatory Affairs Specialist
- Belgian Dutch speaker (Western Europe) page is loaded## Regulatory Affairs Specialist
- Belgian Dutch speaker (Western Europe)remote type: Remotelocations: Virtual Belgium: Virtual Netherlands: Virtual Francetime type: Full timeposted on: Posted Yesterdayjob requisition id: JR102472Who we areWe're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs
- in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.Why WorldwideWe believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join usMake an Impact as a Regulatory Affairs Specialist at WorldwidePlay 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 WorkThis 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.
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at For more information on Worldwide, visit or connect with us on .
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