Regulatory Liaison

ICON; Antwerpen; Sur place; EUR 70 000 - 100 000; Plein temps

Avantages offerts par ce poste

Annual leave

Health insurance

Retirement planning

LifeWorks

Life assurance

Flexible benefits

Résumé du poste

ICON plc in Belgium is seeking a Regulatory Liaison to join our global team. The role acts as the primary regulatory interface for clinical trial teams, ensuring compliance with EU CTR and global regulations, and coordinating timely submissions with partners.

You will work with Regulatory Scientists, Coordinators and external partners to optimize deliverables, maintain documentation, and drive CTR Excellence initiatives while upholding our commitment to inclusion and high standards.

Qualifications

• Bachelor's degree in a relevant scientific discipline or healthcare-related field.
• Strong Regulatory submission and EU CTR experience essential.
• Experience in cross-functional teams.

Responsabilités

• Act as the primary regulatory interface for clinical trial teams, ensuring compliance with EU CTR and global regulations.
• Prepare, review, and coordinate regulatory submission packages with partners.
• Maintain accurate documentation and tracking of regulatory deliverables.
• Collaborate with Regulatory Scientists, Coordinators and External Partners to optimize workload.
• Contribute to CTR Excellence initiatives and process improvements.

Connaissances

Regulatory Expertise

Project Management

Attention to detail

Collaboration

Interpret regulatory guidelines

Problem-solving mindset

Formation

Bachelor's degree in a relevant scientific discipline

Description du poste

Regulatory Liaison

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We are currently seeking a Regulatory liaison to join our diverse and dynamic team. The Regulatory liaison will act as the primary regulatory interface for clinical trial teams, ensuring compliance with global and local regulations, facilitating timely submissions, and maintaining transparency throughout the trial lifecycle. This role bridges regulatory strategy and operational execution, supporting CTR Excellence objectives

This role is fully embedded with a hugely innovative Biotech where pioneering scientists and antibody engineers work side-by-side to accelerate the discovery of novel targets, disease pathways and differentiated therapeutic antibodies within Immunology.

What you will do:

• Represent Regulatory Affairs at Clinical Trial Teams (CTTs) and cross-functional meetings.
• Serve as the main point of contact for clinical trials regulatory matters between argenx and partners.
• Prepare, review, and coordinate regulatory submission packages (CTAs, amendments, IBs, IMPDs) with partners.
• Ensure timely and accurate submissions in compliance with EU CTR, and other regional requirements.
• Monitor delegated activities and maintain oversight of regulatory deliverables.
• Ensure adherence to global and local regulatory standards and company SOPs.
• Liaise with Transparency Lead/Liaisons to ensure compliance with disclosure requirements.
• Maintain accurate documentation and tracking of regulatory activities.
• Contribute to process improvements and best practices within CTR Excellence.
• Collaborate closely with Regulatory Scientists, Regulatory Coordinators and External Partners to optimize workload.

You will have:

• Regulatory Expertise: Strong knowledge of EU Clinical Trial Regulation (CTR) and global regulatory frameworks.
• Project Management:
• Ability to manage complex tasks, prioritize effectively, and meet tight timelines.
• Attention to detail.
• Effectively and proactively collaborates per operating principles to drive assignments.
• Ability to interpret regulatory guidelines and apply them to operational processes.
• Problem-solving mindset: sound judgement and ability to analyse situations and information. Takes decisions based on facts and figures rather than on assumptions

Your Profile:

You will bring relevant regulatory affairs experience, along with the following qualifications and skills.

Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Strong Regulatory submission and EU CTR experience essential
• Experience in cross-functional teams

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here