Regulatory Scientist

ICON plc

Regulatory Scientist at ICON supporting regulatory strategies for clinical programs. Collaborating with cross-functional teams to ensure global compliance for submissions and guiding regulatory outcomes.

Posted 6/4/2026full-timeWarsaw • 🇵🇱 PolandMid-LevelSeniorWebsite

About the role

Key responsibilities & impact

Contributing to regulatory strategy development for clinical programmes, including plans for health authority interactions and submissions
Preparing, reviewing, and coordinating regulatory documents such as clinical trial applications, briefing packages, and responses to health authority questions
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 programmes and submissions
Supporting regulatory interactions and meetings, including preparation of materials and documentation of outcomes

Requirements

What you’ll need

Advanced degree in life sciences, pharmacy, or a related field, or equivalent scientific and regulatory experience
Experience in regulatory affairs, with experience of UK submissions, 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 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

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory strategy developmentregulatory writingclinical trial applicationshealth authority interactionscompliant study designregulatory frameworksclinical developmentdata interpretationregulatory documents preparationregulatory submissions

Soft Skills

analytical skillscritical thinkingwritten communicationverbal communicationattention to detailteam collaborationtime management

Certifications

advanced degree in life sciencesadvanced degree in pharmacy