EU CTR Submissions Lead - CTIS & Regulatory Strategy

Fortrea; Leeds; On-site; GBP 90,000 - 130,000; Full time

Job summary

Fortrea is seeking a Regulatory Submissions Manager II to lead global and regional regulatory submissions, with a strong emphasis on EU CTR and CTIS, across Europe and beyond. The role requires coordinating with project teams, local regulatory bodies, and external authorities to ensure timely approvals and regulatory compliance.

You will own submission strategies, manage timelines, and mentor junior staff while supporting audits, inspections, and process improvements across trial start-up

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• Minimum 4 years of Regulatory Affairs or Clinical Trial Start-up experience.
• Hands-on EU CTR/CTIS experience including submissions and workflows.

Responsibilities

• Own and manage regulatory submissions to RA, IRB/EC, and Third Bodies.
• Track approvals against milestones and timelines.
• Coordinate responses to authority queries within defined timelines.
• Lead or support EU CTR submissions via CTIS and manage user access.
• Mentor junior team members and support process improvements.

Skills

Regulatory submissions

Cross-functional collaboration

Project management

Client-facing

Education

Bachelor’s degree in Life Sciences

Tools

CTIS

Regulatory submission systems

Job description

Fortrea is seeking a Regulatory Submissions Manager II to lead global and regional regulatory submissions, with a strong emphasis on EU CTR and CTIS, across Europe and beyond. The role requires coordinating with project teams, local regulatory bodies, and external authorities to ensure timely approvals and regulatory compliance.

You will own submission strategies, manage timelines, and mentor junior staff while supporting audits, inspections, and process improvements across trial start-up