[Hiring] Senior Regulatory Scientist @ICON plc

Role Description

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 Do:

• Take ownership of regulatory affairs deliverables, applying your expertise to complex challenges.
• Lead or significantly contribute to regulatory strategy development for clinical programmes and key milestones.
• Author and review complex regulatory documents, including clinical trial applications, briefing documents, and major submission components.
• Interpret global regulations, guidelines, and precedents and advise cross-functional teams on regulatory expectations and risk.
• Participate in or lead interactions with health authorities, including meeting preparation, presentation support, and follow-up.
• Provide regulatory input into clinical development plans, risk management strategies, and labelling considerations.
• Mentor junior regulatory staff and contribute to internal standards, templates, and best practices.

Qualifications

• Bachelor's degree in a relevant scientific discipline or healthcare-related field.
• Substantial experience in regulatory affairs or regulatory science within pharma, biotech, or CRO.
• Strong understanding of global clinical development regulations and guidance (e.g., FDA, EMA, ICH).
• Excellent scientific writing, analytical, and critical-thinking skills, with meticulous attention to detail.
• Proven experience supporting or leading health authority interactions and complex submissions.
• Strong communication and collaboration skills, with the ability to work effectively in cross-functional teams.
• Willingness to travel as required (approximately 5%).

Benefits

• 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.