Senior Global Regulatory Scientist

ICON plc

Senior Global Regulatory Scientist at ICON supporting the development and execution of regulatory strategies for clinical programmes. Ensuring compliance with regulatory standards and collaborating with cross-functional teams.

Posted 6/10/2026full-timeSofia • 🇧🇬 BulgariaSeniorWebsite

About the role

Key responsibilities & impact

Take responsibility for regulatory affairs deliverables, applying your skills to ensure quality and efficiency.
Contribute to regulatory strategy development for clinical programmes, including plans for health authority interactions and submissions.
Prepare, review, and coordinate regulatory documents such as clinical trial applications, briefing packages, and responses to health authority questions.
Interpret and apply relevant regulations, guidelines, and precedents to support compliant study design and execution.
Collaborate with clinical, safety, CMC, and other cross-functional teams to ensure alignment of regulatory content and messaging.
Monitor changes in the regulatory environment and provide guidance on potential impact to programmes and submissions.
Support regulatory interactions and meetings, including preparation of materials and documentation of outcomes.

Requirements

What you’ll need

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 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.
Willingness to travel as required (approximately 5%)

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 affairsregulatory writingclinical developmentregulatory documentsclinical trial applicationshealth authority submissionsregulations interpretationguidelines applicationdata analysisscientific research

Soft Skills

analytical skillscritical thinkingwritten communicationverbal communicationattention to detailteam collaborationtime managementorganizational skillsproblem-solvingadaptability