📄 Lead Regulatory Excellence as Senior Regulatory Submission Specialist - Australia (Home-Based)
Join ICON plc as a Senior Regulatory Submission Specialist and become the driving force behind successful clinical trial approvals across Australia and New Zealand. This home-based role offers the perfect blend of strategic impact and flexible work arrangements, allowing you to shape regulatory submissions while working from anywhere in Australia.
🎯 Your Impact: Key Responsibilities
End-to-End Submission Leadership
- Deliver comprehensive regulatory submission activities in alignment with study requirements, ICON procedures, and Australian/New Zealand regulations
- Prepare, adapt, coordinate, and collate high-quality submission documentation for Regulatory Agencies and Ethics Committees
- Manage the complete lifecycle of submissions from initial preparation through to final approval
- Contribute to submission strategy planning with proactive risk identification and mitigation
Regulatory Intelligence & Compliance
- Maintain strong working knowledge of ICH-GCP, TGA, Medsafe requirements, and clinical trial legislation
- Interact directly with regulatory and ethics bodies as required for submission progression
- Support collection and maintenance of regional regulatory intelligence
- Ensure all activities comply with ICON SOPs and project-specific requirements
Stakeholder Management & Communication
- Keep project teams informed of all regulatory milestones, approvals, and potential challenges
- Collaborate with regional and global colleagues to meet study deliverables and timelines
- Flag out-of-scope work and support budget adherence through clear communication
- Coordinate translation requirements in accordance with project needs
Process Excellence & Mentorship
- Track submission progress and maintain accurate records in CTMS, eTMF, and relevant systems
- Contribute to process improvement initiatives that streamline workflows and add value
- Mentor junior team members and participate in system/procedure reviews
- Embrace digital innovation and smarter ways of working in regulatory operations
⭐ Your Profile: Qualifications & Experience
Essential Requirements
- Minimum 3 years of relevant regulatory experience in CRO or pharmaceutical company
- Strong working knowledge of Australian and New Zealand regulatory requirements
- Experience with ethics committee processes and clinical trial legislation
- Proven track record in managing regulatory submissions from preparation to approval
Technical Competencies
- Familiarity with CTMS, eTMF, and regulatory tracking systems
- Understanding of ICH-GCP guidelines and regional implementation
- Experience with submission documentation preparation and coordination
- Knowledge of regulatory intelligence gathering and application
Professional Attributes
- Excellent organizational skills with ability to manage competing priorities
- Proactive, solutions-focused approach with continuous improvement mindset
- Strong communication and stakeholder engagement capabilities
- Commitment to delivering high-quality work and supporting team success
Personal Qualities
- Forward-thinking with interest in process improvement and digital innovation
- Ability to thrive in fast-paced global environment
- Ownership mentality with attention to detail
- Collaborative spirit with commitment to team success
💫 Why Join ICON in Australia?
Strategic Impact
- Play pivotal role in accelerating clinical development across Australia and New Zealand
- Contribute to bringing innovative treatments to patients faster
- Shape regulatory submission strategies for global clinical trials
- Influence process improvement and digital innovation in regulatory operations
Home-Based Flexibility
- Work from anywhere in Australia with flexible remote arrangement
- Balance professional responsibilities with personal lifestyle preferences
- Avoid commute while maintaining high-level professional collaboration
- Modern technology infrastructure for seamless virtual teamwork
Professional Growth
- Clear pathway to Regulatory Leadership and Management roles
- Exposure to diverse therapeutic areas and complex study designs
- Opportunities for professional development and advanced training
- Global networking within ICON's international regulatory community
Meaningful Work
- Contribute to ICON's purpose of improving lives by accelerating medicine development
- Support clinical trials that address healthcare needs in Australia and beyond
- Ensure regulatory compliance while driving innovation in clinical development
- Be part of team that values smarter ways of working and better patient experiences
Competitive Australia Benefits
- Attractive salary package with performance incentives
- Comprehensive health insurance for you and your family
- Global Employee Assistance Programme with 24/7 support
- Generous annual leave with Australian public holidays
Career Development
- Retirement planning through superannuation benefits
- Life assurance coverage
- Professional development allowance and training opportunities
- Health and wellness programs
- Technology support for home office setup
✨ Ready to Drive Regulatory Success from Home?
If you're an experienced regulatory professional with passion for quality and innovation, we encourage you to apply. This Senior Regulatory Submission Specialist role offers the unique opportunity to lead submission excellence while enjoying the flexibility of home-based work across Australia.
Apply Now & Shape the Future of Clinical Trials in Australia!
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ICON is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
We welcome applications from all qualified regulatory professionals across Australia - your submission expertise and commitment to quality might be exactly what we need at ICON!
