Regulatory Technician

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

Regulatory Technician

As a Regulatory Technician you will be collaborating with key stakeholders to manage and complete data entry and document upload to and monitoring of Clinical Trial Regulatory systems/portals according to study specifics, ICON policies, procedures, applicable regulations and the principles of ICH-GCP with in line with contractual agreement. You will also support regulatory submissions and deliverables to meet department and project goals.

Duties and Responsibilities

• Recognize, exemplify and adhere to ICON's values which centre around our commitment to People, Clients and Performance
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
• Ensure Regulatory deliverables are performed in accordance with all relevant regulations, guidelines, policies and procedures within contractual timelines and budget
• Knowledge of ICON’s SOPs/WIs, ICH, GCP, appropriate regulations and guidance
• Knowledge of ICON systems applicable to role
• Proficient in using applicable business applications
• Successfully complete internal/external training for applicable Clinical Trial Regulatory system/portal to complete Regulatory submissions
• Standard expertise of applicable Clinical Trial Regulatory system/portal
• Proactively identify and mitigate risks through Regulatory Authority helpdesks or internal sources, regarding data/document management and upload to Clinical Trial Regulatory systems/portals and liaise with internal/external stakeholders to resolve
• Actively maintain applicable study-level account access for assigned projects for Clinical Trial Regulatory systems/portals to maintain compliance and confidentiality
• Collaborate with key stakeholders to manage and perform data entry and document upload to required country/regional Clinical Trial Regulatory systems/portals using the data and documents provided by project team
• Monitor Clinical Trial Regulatory systems/portals for notices and alerts and notifying applicable stakeholders of activities for their action and subsequent follow up
• Create files documenting submissions completed through Regulatory systems/portals, conclusions, decisions and any other communication provided via Regulatory systems/portals
• Perform Quality Control review in accordance with applicable process
• Maintain agreed timelines
• Support other Regulatory deliverables under the direction of leadership, as required
• Ensure project-specific training is completed on time, as applicable
• Travel (approximately 5%) domestic and /or international

Read and Write fluent English.

What ICON can offer you:

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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.