Regulatory Technician

• 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

• 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

• 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