Site Specialist II

KCR Placement; Sydney; Hybrid; AUD 140,000 - 190,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

Employee assistance program

Life insurance

Flexible country-specific benefits

Job summary

ICON is a global healthcare intelligence and clinical research organisation focused on bringing new medicines to patients faster. We are seeking a Senior Regulatory Scientist to provide advanced regulatory and scientific expertise for global development strategies, submissions and health authority interactions, with a home-based role in Australia.

You will lead regulatory strategy, author complex documents, interpret global regulations, mentor staff, and collaborate across cross-functional teams

Qualifications

• Bachelor's degree in a relevant scientific discipline or healthcare-related field.
• Substantial experience in regulatory affairs or regulatory science within pharma, biotech, or CRO.
• Strong understanding of global clinical development regulations and guidance (e.g., FDA, EMA, ICH).
• Excellent scientific writing, analytical, and critical-thinking skills, with meticulous attention to detail.
• Proven experience supporting or leading health authority interactions and complex submissions.
• Strong communication and collaboration skills, with the ability to work effectively in cross-functional teams.
• Willingness to travel as required (approximately 5%).

Responsibilities

• Leading or significantly contributing to regulatory strategy development for clinical programmes and key milestones.
• Authoring and reviewing complex regulatory documents, including clinical trial applications, briefing documents, and major submission components.
• Interpreting global regulations, guidelines, and precedents and advising cross-functional teams on regulatory expectations and risk.
• Participating in or leading interactions with health authorities, including meeting preparation, presentation support, and follow-up.
• Providing regulatory input into clinical development plans, risk management strategies, and labelling considerations.
• Mentoring junior regulatory staff and contributing to internal standards, templates, and best practices.

Skills

Regulatory affairs

Education

Bachelor's degree in a relevant scientific field

Job description

Senior Regulatory Scientist, Home-based in Australia

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 Regulatory Scientist at ICON, you will provide advanced regulatory and scientific expertise to support global clinical development strategies, submissions, and health authority interactions. You will help navigate complex regulatory landscapes to enable successful programme execution.

What You Will Do:

You will take ownership of regulatory affairs deliverables, applying your expertise to complex challenges. Key responsibilities include:

• Leading or significantly contributing to regulatory strategy development for clinical programmes and key milestones.
• Authoring and reviewing complex regulatory documents, including clinical trial applications, briefing documents, and major submission components.
• Interpreting global regulations, guidelines, and precedents and advising cross-functional teams on regulatory expectations and risk.
• Participating in or leading interactions with health authorities, including meeting preparation, presentation support, and follow-up.
• Providing regulatory input into clinical development plans, risk management strategies, and labelling considerations.
• Mentoring junior regulatory staff and contributing to internal standards, templates, and best practices.

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
• Substantial experience in regulatory affairs or regulatory science within pharma, biotech, or CRO.
• Strong understanding of global clinical development regulations and guidance (e.g., FDA, EMA, ICH).
• Excellent scientific writing, analytical, and critical-thinking skills, with meticulous attention to detail.
• Proven experience supporting or leading health authority interactions and complex submissions.
• Strong communication and collaboration skills, with the ability to work effectively in cross-functional teams.
• Willingness to travel as required (approximately 5%)

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well‑being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24‑hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well‑being.
• Life assurance
• Flexible country‑specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here