Regulatory Affairs Specialist- Belgian Dutch speaker- Remote

Worldwide Clinical Trials Limited; Belgique; Remote; EUR 60,000 - 90,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Regulatory submissions coordination

Clinical research experience

ICH GCP knowledge

Regulatory documentation review

English and Dutch language skills

Education

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

Tools

MS Office (Word, Excel, PowerPoint)

Job description

Who we are We’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 3,5+ 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 Worldwide

We 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 us!

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.

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 Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.

This is who we are. We’re a team of clinicians, scientists, and researchers who want to make healthcare better. We were founded on an unwavering commitment to authentic, personalized attention. And today, as CROs consolidate and the industry changes rapidly, that personalized attention is more important than ever. We all came to this industry for different reasons, from different walks of life. If you ask any one of us why we’re here, you’ll get a different answer. And that’s what makes us special.