Senior Global Regulatory Scientist

ICON plc

. Lead the development of global regulatory strategies for clinical programmes, including plans for key health authority interactions and milestones .

Posted 10/9/2026full-timeSydney • AustraliaSeniorWebsite

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 clinical development regulations and the ability to communicate effectively with health authorities. Proven ability to mentor colleagues and contribute to best practices in regulatory affairs.

Highest-signal resume keywords

Regulatory AffairsClinical Trial ApplicationsGlobal Clinical Development RegulationsHealth Authority InteractionsAnalytical Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentRegulatory Document AuthoringRisk Management StrategiesClinical Development PlansData Interpretation

Soft Skills

Communication SkillsMentoringAttention to DetailCritical Thinking

Industry Keywords

PharmaBiotechCROFDAEMAICH

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, briefing books, and major submission components
Interpret evolving global regulations, guidelines, and precedents, and advise teams on implications for programme design and execution
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 and 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 (e.g., FDA, EMA, ICH) and regional requirements
Excellent scientific, analytical, and critical-thinking skills, with the ability to integrate complex data into regulatory positions
Outstanding written and verbal communication abilities, with meticulous attention to detail
Proven experience interacting with health authorities and 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