Senior Global Regulatory Scientist

ICON plc

Senior Global Regulatory Scientist shaping global clinical submission strategies at ICON, a healthcare intelligence and clinical research organisation. Advising development teams, interacting with health authorities, and mentoring regulatory colleagues.

Posted 8/4/2026full-timeRemote • 🇬🇧 United KingdomSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing global regulatory strategies and authoring complex regulatory documents, with a strong understanding of FDA, EMA, and ICH regulations. Proven ability to mentor colleagues and effectively communicate with health authorities while integrating complex data into regulatory positions.

Highest-signal resume keywords

Regulatory Affairs ExperienceGlobal Clinical Development RegulationsHealth Authority InteractionCross-Functional Project LeadershipScientific Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentClinical Trial ApplicationsRisk Management StrategiesData IntegrationRegulatory Document Review

Soft Skills

Analytical SkillsCritical ThinkingAttention to DetailMentoringVerbal Communication

Industry Keywords

PharmaBiotechCROFDAEMAICHRegulatory ScienceClinical DevelopmentHealth Authority MeetingsBest Practices

About the role

Key responsibilities & impact

Lead the development of global regulatory strategies for clinical programmes, including plans for key health authority interactions and milestones
Author and review complex regulatory documents such as clinical trial applications and major submission components
Interpret evolving global regulations, guidelines, and precedents, advising teams on programme design and execution implications
Provide strategic input into clinical development plans, risk management strategies, and labelling considerations
Represent regulatory functions in sponsor and health authority meetings, ensuring clear, scientifically robust communication
Mentor junior regulatory colleagues
Contribute to internal best practices, templates, and knowledge-sharing initiatives

Requirements

What you’ll need

Bachelor's degree in a relevant scientific discipline or healthcare-related field
Extensive experience in regulatory affairs or regulatory science within pharma, biotech, or CRO environments
Strong knowledge of global clinical development regulations, including FDA, EMA, and ICH, and regional requirements
Excellent scientific, analytical, and critical-thinking skills
Ability to integrate complex data into regulatory positions
Outstanding written and verbal communication abilities
Meticulous attention to detail
Proven experience interacting with health authorities
Proven experience leading cross-functional regulatory projects
Willingness to travel as required, approximately 10%
Legal right to work in the country where the role is based

Benefits

Comp & perks

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
Reasonable accommodations during the recruitment process
Inclusive and accessible workplace