Compliance

• Own and manage Regulatory Authority (RA), IRB/EC, and Third Body submissions for assigned clinical trials
• Develop submission strategy, planning, and timeline management
• Track approvals against project milestones (GL, RTE)
• Coordinate responses to authority queries within defined timelines
• Lead or support EU CTR submissions via CTIS
• Prepare, submit, and maintain CTIS applications
• Manage CTIS user access and act as CTIS back-up when required
• Advise internal teams on CTR/CTIS processes and expectations
• Prepare, review, and quality-check core and country-specific regulatory submission packages
• Ensure deliverables comply with applicable regulations, guidance, SOPs, and client requirements
• Provide regulatory guidance by maintaining up-to-date knowledge of global and EU regulatory requirements
• Liaise with or support local teams in communications with Regulatory Authorities, Ethics Committees, and Third Bodies
• Identify and proactively escalate risks to timelines, quality, or approvals
• Support audits, inspections, and resolution of findings
• Contribute to process improvement initiatives, including SOP development and optimization
• Mentor junior team members and support team capability building

Explore Regulatory Submissions Manager II at Fortrea. Review requirements and application details.

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