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ICON plc
ICON plc
ConsultingHealthcareLogistics
ICON plc is a global contract research organisation serving the healthcare and pharmaceutical industries. Its work spans clinical, consulting, and commercial services that support drug development from early research through post-marketing activities. The company provides solutions including decentralised clinical trials, cardiac safety, early clinical laboratories, medical imaging, regulatory intelligence, and real-world evidence. ICON plc also brings therapeutic expertise to areas such as cardiovascular disease, oncology, internal medicine, cell and gene therapies, and biosimilars, combining data analysis with patient-focused approaches to help advance clinical programmes.
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Regulatory Technician – CTIS Submissions | ICON plc | Spain Remote

Support CTIS data management, document uploads, and regulatory submissions for ICON plc’s clinical research operations. Coordinate submission activities and stakeholder follow-up to help advance medicines to patients.

ESSpainRemoteFull-timeMiddleSeniorEnglish RequiredCompliance
Assembly

Description

  • Manage activities in the Clinical Trials Information System (CTIS)
  • Support submissions and related documents, including their assembly and dispatch
  • Coordinate resources supporting regulatory submissions
  • Identify and help mitigate CTIS data-management and document-upload risks through helpdesk support
  • Work with internal and external stakeholders to resolve submission-related issues
  • Maintain study-level account access for assigned CTIS projects
  • Complete data entry and upload documents in CTIS
  • Monitor CTIS activity and alert relevant stakeholders when action or follow-up is needed
  • Prepare records of CTIS submissions, conclusions, decisions, and communications
  • Conduct quality-control reviews in line with applicable procedures
  • Keep submission work aligned with agreed timelines
  • Complete project-specific training within the required timeframe

Requirements

  • Advanced English proficiency is required for speaking, reading, and writing
  • One to two years of relevant clinical research experience or familiarity with clinical terminology and documentation is preferred
  • Able to work independently
  • Regulatory submission and CTIS experience is advantageous but not required
  • Must have the legal right to work in the country where the role is based

Benefits

  • Base salary with 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
  • Structured training and career development pathways
  • Reasonable accommodations throughout the recruitment process
  • Inclusive and accessible workplace

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