Job Description

Senior Regulatory Scientist - Johannesburg, South Africa - Homebased
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
The Role:
As a Senior Regulatory Scientist, you will be responsible for completing country and/or regional clinical trial regulatory deliverables in line with study specifics, ensuring compliance with ICH-GCP, relevant regulations, and sound scientific principles. You will also contribute to process improvement initiatives, mentor junior staff as needed, and provide strategic input into submissions planning.
Key Responsibilities:
Deliver regulatory submissions in accordance with contractual timelines, budget, and quality standards.
Apply advanced knowledge of ICON SOPs/WIs, ICH-GCP, and local regulatory requirements.
Contribute to strategic planning of submissions to Regulatory Authorities (RA), Central Ethics Committees (CEC), and other applicable bodies.
Prepare, adapt, coordinate, and collate submission documentation per study and country requirements.
Manage internal and external reviews of regulatory documentation and ensure accuracy of data in systems such as CTMS and eTMF.
Oversee translation management and submission lifecycle through approval.
Maintain proactive communication with project teams to ensure timely updates on submission and approval status.
Collaborate cross-functionally to ensure regulatory deliverables are met.
Support maintenance of up-to-date clinical trial regulatory intelligence across global and regional levels.
Mentor junior team members and contribute to the ongoing enhancement of ICON's regulatory processes.
You Are:
Educated to degree level in life sciences or related discipline.
Experienced with a minimum of 3 years' relevant regulatory experience in clinical research.
Fluent in English and the local country language.
Highly organized with excellent attention to detail and ability to manage multiple priorities.
A strong communicator with the ability to engage internal teams and external stakeholders effectively.
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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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.
Visit our 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 .
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 to apply

Skills Required