Regulatory Submissions Lead — EU CTR/CTIS Expert

Fortrea; Portugal; On-site; EUR 55,000 - 75,000; Full time

Job summary

Fortrea is seeking a Regulatory Submissions Assistant Manager II to support global clinical trials through high-quality regulatory submissions across Europe and beyond. You will ensure timely approvals and regulatory compliance, with a strong focus on EU CTR and CTIS operations in a matrix, client-facing environment.

You will own and manage RA, IRB/EC, and third-body submissions, coordinate responses to authority queries, prepare core regulatory packages, and mentor junior team members while

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Minimum 4 years of regulatory affairs, regulatory submissions, or start-up experience in pharma/biotech/CRO.
• Hands-on experience with EU CTR and CTIS, including applications and workflows.
• Solid understanding of RA, IRB/EC, and third-body submission processes.

Responsibilities

• Own and manage RA, IRB/EC, and Third Body submissions for clinical trials; plan, track approvals, and coordinate responses to authority queries.
• Lead or support EU CTR submissions via CTIS; prepare, submit, and maintain CTIS applications and manage user access.
• Prepare, review, and quality-check core regulatory packages and country-specific submission packages.
• Ensure deliverables comply with regulations, guidance, SOPs, and client requirements; provide regulatory guidance to project teams.

Skills

Regulatory submissions

EU CTR/CTIS

Cross-functional collaboration

Project coordination

Education

Bachelor’s degree in Life Sciences

Tools

CTIS

Job description

Fortrea is seeking a Regulatory Submissions Assistant Manager II to support global clinical trials through high-quality regulatory submissions across Europe and beyond. You will ensure timely approvals and regulatory compliance, with a strong focus on EU CTR and CTIS operations in a matrix, client-facing environment.

You will own and manage RA, IRB/EC, and third-body submissions, coordinate responses to authority queries, prepare core regulatory packages, and mentor junior team members while