Description
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 Senior Regulatory Scientist at ICON, you will provide advanced regulatory and scientific expertise to support global clinical development strategies, submissions, and health authority interactions.
Responsibilities
- 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.
Your Profile
- 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%)
Rewards & 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