Regulatory Technician

South Africa

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.

Summary of the Role
The Regulatory Technician will work closely with project teams and functional partners to ensure accurate data entry, document upload and ongoing management within the Clinical Trials Information System. The successful candidate will support regulatory submissions, maintain compliance with applicable guidelines, and uphold the highest standards of accuracy, confidentiality and operational excellence.

Key Responsibilities
• Collaborate with key stakeholders to manage and perform data entry and document upload to the Clinical Trials Information System using data and documents supplied by the project team
• Complete all data entry and document upload activities in alignment with study specifics, ICON policies and procedures, applicable regulations and ICH GCP, and in accordance with contractual requirements
• Monitor the system for notices and alerts, communicating required actions to relevant stakeholders and ensuring timely follow up
• Create and maintain files documenting submissions, conclusions, decisions and all communication received through the system
• Actively maintain study level account access for assigned projects to ensure compliance and confidentiality
• Ensure timely completion of all project specific training
 

Core Requirements
• Ability to read, write and speak fluent English
• Commitment to exemplifying ICON values with a focus on People, Clients and Performance
• Knowledge of ICH, GCP and appropriate regulations and guidance
• Standard expertise in use of the system to support regulatory submissions
• Strong organisational and time management skills with the ability to meet defined timelines
• Excellent written and verbal communication skills with strong attention to detail
• Ability to work effectively in a collaborative team environment
• A proactive and solution focused mindset with a commitment to quality and continuous improvement

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

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 to apply

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