Regulatory Liaison

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

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

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

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

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply