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.
About the role
We are currently seeking a Senior Regulatory Scientist to join our diverse and dynamic team. As a Senior Regulatory Scientist at ICON, you will provide advanced regulatory and scientific expertise to support global clinical development strategies, submissions, and health authority interactions. You will help navigate complex regulatory landscapes to enable successful programme execution.
What You Will Be Doing:
•
Leading or significantly contributing to regulatory strategy development for clinical programmes and key milestones.
•
Authoring and reviewing complex regulatory documents, including clinical trial applications, briefing documents, and major submission components.
•
Interpreting global regulations, guidelines, and precedents and advising cross-functional teams on regulatory expectations and risk.
•
Participating in or leading interactions with health authorities, including meeting preparation, presentation support, and follow-up.
•
Providing regulatory input into clinical development plans, risk management strategies, and labelling considerations.
•
Mentoring junior regulatory staff and contributing to internal standards, templates, and best practices.