Senior Global Regulatory Scientist

ICON Clinical Research; Sydney; On-site; AUD 180,000 - 240,000; Full time

Job summary

ICON Clinical Research in Sydney is seeking a Senior Regulatory Scientist to lead global regulatory strategies and drive submissions across clinical programmes. You will mentor colleagues, interact with health authorities, and shape regulatory positions for development programs.

With a strong regulatory affairs background, you will interpret FDA/EMA/ICH requirements, author complex documents, and collaborate cross-functionally.

Qualifications

• Strong foundation in regulatory affairs and the ability to work independently
• Experience navigating FDA/EMA/ICH and global regulatory requirements
• Excellent written and verbal communication with meticulous attention to detail
• Proven ability to mentor colleagues and lead cross-functional regulatory projects

Responsibilities

• Lead development of global regulatory strategies for clinical programmes
• Author and review complex regulatory documents (DAs, briefing books, major submissions)
• Interpret evolving global regulations and advise on programme design
• Provide strategic input to development plans and labeling considerations
• Represent regulatory functions in sponsor and health authority meetings
• Mentor junior regulatory colleagues and contribute to internal best practices

Skills

Regulatory strategy

Regulatory science

Mentoring

Communication

Cross-functional collaboration

Education

Bachelor's degree in a relevant scientific discipline

Job description

Senior Regulatory Scientist, Sydney - Office Based

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 include:

• 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, briefing books, 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.
• 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.

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.

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 requesthere.