Regulatory Affairs Specialist- Belgian Dutch speaker- Remote

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, a global team of over 3,500 experts, bright thinkers, dreamers and doers, 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.

What the Regulatory Affairs Department Does at Worldwide
Regulatory Affairs plays a pivotal role in navigating the complex regulatory landscape, ensuring the success of diverse clinical trials. As subject‑matter experts, the team leads submissions to regulatory authorities, coordinates with ethics committees across EMEA, Asia Pacific, and Latin America, and ensures compliance with evolving regulations. Their expertise drives the development and approval of innovative medical products, supports business development efforts, and offers strategic guidance on contract negotiations.

They also mentor junior staff, review key documentation for global regulatory standards, and keep all stakeholders informed throughout the submission process.

What You Will Do

Liaise with SAR colleagues to plan, organize, compile, progress, track and submit regulatory submissions on a timely basis

Act as a contact point for translation review of submissions documents such as application, synopsis, ICF, labels, etc.

Provide local QC of submission dossiers prior to dispatch where required

Communicate to the SAR Lead and relevant project team members the status and action plans concerning submissions

Identify risks and generate mitigation strategies

Foster professional working relationships with internal and external contacts to ensure expeditious submission/approval of regulatory dossiers

Maintain country‑specific patient information sheet and consent form customization text

Maintain country‑specific drug labeling information

Maintain Country Intelligence Pages

Be familiar with and comply with SOPs, ICH GCP and applicable regulations

Stay informed of changing regulatory legislative requirements and maintain regulatory intelligence database

Advise the SAR project team about appropriate regulatory strategies

Review and make recommendations on all relevant documentation (labels, patient information sheets, diary cards, etc.) to comply with ICH GCP & country‑specific requirements

Provide timely and relevant updates and communication of changes in the regulatory environment to the Regulatory Affairs department

Provide advice to the Regulatory Affairs department on interpretation of new legislation, guidance and directives

What You Will Bring To

The Role

Strong organizational and management skills

Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills

Self‑motivated learning about current regulatory processes and intelligence

Excellent written and verbal communication skills to clearly and concisely present information

Team‑oriented work style; seeks and gives guidance to others

Strong interpersonal skills in a fast‑paced, deadline‑oriented, and changing environment

Excellent ability to handle multiple tasks in a fast‑paced and changing environment

Proficiency in all MS‑Office applications including Microsoft Word, Excel, and Power Point

Aptitude for contemporary digital systems is helpful

Your Experience

Degree with a major concentration in medical, biological, physical, health, pharmacy or…