Regulatory Scientist

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 Regulatory Scientist at ICON, you will support the development, implementation, and execution of regulatory strategies for clinical development programs.

Responsibilities

• Preparing, reviewing, and coordinating regulatory documents such as clinical trial applications, briefing packages, and responses to health authority questions.
• Contributing to regulatory strategy development for clinical programs, including plans for health authority interactions and submissions.
• Interpreting and applying relevant regulations, guidelines, and precedents to support compliant study design and execution.
• Collaborating with clinical, safety, CMC, and other cross-functional teams to ensure alignment of regulatory content and messaging.
• Monitoring changes in the regulatory environment and providing guidance on potential impact to programs and submissions.
• Supporting regulatory interactions and meetings, including preparation of materials and documentation of outcomes.

Your Profile

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Experience in regulatory affairs, regulatory writing, or clinical development within the pharma, biotech, or CRO industry.
• Good understanding of global regulatory frameworks and guidelines relevant to clinical development.
• Strong scientific, analytical, and critical thinking skills, with the ability to interpret complex data and regulations.
• Excellent English - written and verbal communication skills, with high attention to detail and accuracy.
• Ability to work effectively in cross-functional teams and manage multiple regulatory activities and timelines.

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