Compliance

• Responsible for completing country and/or regional clinical trial regulatory deliverables in line with study specifics.
• Ensure compliance with ICH-GCP, relevant regulations, and sound scientific principles.
• Contribute to process improvement initiatives, mentor junior staff as needed.
• Provide strategic input into submissions planning.
• Deliver regulatory submissions in accordance with contractual timelines, budget, and quality standards.
• Apply advanced knowledge of ICON SOPs/WIs, ICH-GCP, and local regulatory requirements.
• Prepare, adapt, coordinate, and collate submission documentation per study and country requirements.
• Manage internal and external reviews of regulatory documentation.
• Oversee translation management and submission lifecycle through approval.
• Maintain proactive communication with project teams to ensure timely updates on submission and approval status.
• Collaborate cross-functionally to ensure regulatory deliverables are met.
• Support maintenance of up-to-date clinical trial regulatory intelligence across global and regional levels.
• Mentor junior team members and contribute to the ongoing enhancement of ICON’s regulatory processes.

Senior Regulatory Scientist

Senior Global Regulatory Scientist