28 Nov
ICON Clinical Research
Sydney
Senior Regulatory Submission Specialist to join us in a home-based in Australia
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive workplace driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
**Senior Regulatory Submission Specialist**
**Location:** Home-based in Australia
**Join a global leader shaping the future of clinical research**
At ICON, we're driven by a simple purpose: to improve lives by accelerating the development of life-changing medicines. Our commitment to People, Clients and Performance is at the heart of everything we do. As we continue to grow, we're looking for a **Senior Regulatory Submission Specialist** who's passionate about quality, collaboration and driving smarter ways of working.
**The Opportunity**
In this pivotal role, you'll lead and deliver high-quality clinical trial regulatory submissions across Australia and New Zealand. You'll apply strong scientific and technical expertise, ensuring every submission aligns with ICH-GCP, local regulations, ICON SOPs and project-specific requirements.
This role suits someone who enjoys ownership, thrives in a fast-paced global environment and brings a forward-thinking mindset to process improvement and digital innovation.
**What You'll Do**
+ Deliver all regulatory submission activities in line with study requirements, ICON procedures, applicable regulations and contractual timelines.
+ Prepare, adapt, coordinate and collate high-quality submission documentation for Regulatory Agencies (RA), Central Ethics Committees (CEC) and other authorities.
+ Contribute to submission strategy planning, including proactive risk identification and mitigation.
+ Interact directly with regulatory and ethics bodies as required.
+ Manage the end-to-end lifecycle of submissions through to approval.
+ Track submission progress and maintain complete, accurate records in CTMS, eTMF and other relevant systems.
+ Coordinate translation requirements in accordance with project needs.
+ Flag out-of-scope work and support budget adherence.
+ Keep project teams informed of all relevant regulatory milestones and approvals.
+ Collaborate with regional and global colleagues to meet study deliverables.
+ Support the collection and maintenance of global/regional/country regulatory intelligence.
+ Contribute to process improvement initiatives that streamline ways of working and add value.
+ Mentor junior team members and participate in system/procedure reviews, depending on experience.
+ Complete all study-specific training on time and uphold ICON's quality and compliance standards.
+ Take on any additional responsibilities needed to support ICON's success.
**What You'll Bring**
+ Minimum **3 years of relevant regulatory experience** in a CRO or pharmaceutical company.
+ Strong working knowledge of ICH-GCP, regional regulatory requirements, ethics committee processes and clinical trial legislation.
+ Excellent organisational skills with a knack for managing competing priorities.
+ A proactive, solutions-focused approach with a continuous improvement mindset.
+ Strong communication and stakeholder-engagement skills.
+ A genuine commitment to delivering high-quality work and supporting team success.
**Why Join ICON?**
You'll be part of a team that values innovation, collaboration and professional growth. We empower our people to challenge the status quo, embrace smarter technologies and create better experiences for sites, sponsors and-ultimately-patients.
If you're ready to step into a role where your expertise has real impact and your ideas are welcomed, we'd love to hear from you.
**Apply today and help shape the future of clinical trials.**
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**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 (https://careers.iconplc.com/benefits) 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 (https://careers.iconplc.com/reasonable-accommodations)
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here (https://wd3.myworkday.com/icon/d/task/1422$1235.htmld) to apply
📌 Senior Regulatory Submission Specialist (Sydney)
🏢 ICON Clinical Research
📍 Sydney
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