Senior Global Regulatory Scientist

ICON Clinical Research Ltd; Dublin; On-site; EUR 90,000 - 135,000; Full time

Benefits offered by this job

Health insurance

Pension plan

Career development opportunities

Job summary

ICON Clinical Research Ltd in Ireland is seeking a Senior Global Regulatory Scientist to provide high-level regulatory and scientific expertise to support global development strategies and submissions. You will lead regulatory strategy for clinical programmes, author and review major submission components, and mentor junior colleagues while guiding teams through evolving regulations.

Willingness to travel (approx.

Qualifications

• Bachelor's degree in a relevant scientific discipline or healthcare field.
• Extensive experience in regulatory affairs or regulatory science within pharma, biotech, or CRO environments.
• Strong knowledge of global clinical development regulations (FDA, EMA, ICH) and regional requirements.
• Excellent scientific, analytical, and critical-thinking skills with data integration.
• Outstanding written and verbal communication, meticulous attention to detail.
• Proven experience interacting with health authorities and leading cross-functional projects.

Responsibilities

• Leading the development of global regulatory strategies for clinical programmes, including plans for health authority interactions and milestones.
• Authoring and reviewing complex regulatory documents such as clinical trial applications and major submission components.
• Interpreting evolving global regulations, guidelines, and precedents, and advising teams on implications for programme design and execution.
• Providing strategic input into clinical development plans, risk management strategies, and labelling considerations.
• Representing regulatory functions in sponsor and health authority meetings, ensuring clear, scientifically robust communication.
• Mentoring junior regulatory colleagues and contributing to internal best practices and knowledge sharing.

Skills

Regulatory strategy

Regulatory affairs

Cross-functional leadership

Scientific analysis

Communication

Project management

Education

Bachelor's degree in a relevant scientific discipline

Job description

As a Senior Global Regulatory Scientist at ICON, you will provide high-level regulatory and scientific expertise to support global development strategies and submissions. 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 values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. As a Senior Global Regulatory Scientist at ICON, you will provide high-level regulatory and scientific expertise to support global development strategies and submissions.

What You Will Do

Your experience in regulatory affairs will be key in delivering high-quality outcomes and mentoring colleagues.

Key responsibilities

• Leading the development of global regulatory strategies for clinical programmes, including plans for key health authority interactions and milestones.
• Authoring and reviewing complex regulatory documents such as clinical trial applications, and major submission components.
• Interpreting evolving global regulations, guidelines, and precedents, and advising teams on implications for programme design and execution.
• Providing strategic input into clinical development plans, risk management strategies, and labelling considerations.
• Representing regulatory functions in sponsor and health authority meetings, ensuring clear, scientifically robust communication.
• Mentoring junior regulatory colleagues and contributing to internal best practices, templates, and knowledge-sharing initiatives.

Your Profile

You will have a strong foundation in regulatory affairs, with the experience to work independently and guide others.

Required qualifications and experience

• 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 is essential.
• 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%) Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include:

• 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

Benefits may vary depending on role and location. Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.