Regulatory Technician
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Job Description
Regulatory Technician managing CTIS data, document uploads, and submission support. Supporting ICON’s global clinical research organisation in bringing medicines to patients faster.
Responsibilities:
- Work with the Clinical Trials Information System (CTIS)
- Provide support for submissions and other documents, including assembly and dispatch
- Coordinate resources for submissions
- Proactively identify and mitigate risks through CTIS helpdesks regarding data/document management and upload to CTIS
- Liaise with internal and external stakeholders to resolve issues
- Maintain applicable study-level account access for assigned CTIS projects
- Manage and perform data entry and document uploads
- Monitor CTIS and notify applicable stakeholders of activities for action and follow-up
- Create files documenting CTIS submissions, conclusions, decisions, and communications
- Perform quality control reviews according to applicable processes
- Maintain agreed timelines
- Ensure project-specific training is completed on time
Requirements:
- Mandatory advanced English (speak, read, write)
- Ideally 1-2 years relevant experience within clinical research or knowledge of clinical terminology and documentation
- Ability to work independently
- Experience with regulatory submissions and CTIS is a differential but not mandatory
- Legal right to work in the country where the role is based
Benefits:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
- Reasonable accommodations during the recruitment process
- Inclusive and accessible workplace
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