# Senior Regulatory Scientist

**Company**: ICON
**Location**: Sydney
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/Australia-Sydney/Site-Specialist-II_JR151027?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/job/senior-regulatory-scientist-89dff96d-818/

## Description

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 Senior Regulatory Scientist at ICON, you will provide advanced regulatory and scientific expertise to support global clinical development strategies, submissions, and health authority interactions.

**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.

**Your Profile**

- 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%)

**Rewards & Benefits**

- 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

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## Skills

### Required
- regulatory affairs
- clinical development
- health authority interactions
- scientific writing
- analytical skills
- critical thinking

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