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Johannesburg, Gauteng, South Africa
Onsite
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.
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.
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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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply