Regulatory Submissions Lead – EU CTR/CTIS Expert

Fortrea; Polska; On-site; PLN 180,000 - 240,000; Full time

Job summary

Fortrea is seeking a Regulatory Submissions Ass Manager II to support global and regional clinical trials through high‑quality regulatory submissions across Europe and beyond.

This role focuses on EU CTR and CTIS operations, working in a matrix, client‑facing environment with project teams, start‑up leads, local regulatory teams, and external authorities. You will ensure timely approvals and regulatory compliance.

Qualifications

• Bachelor’s degree in Life Sciences or related field (or equivalent experience).
• Minimum 4 years of experience in Regulatory Affairs, Regulatory Submissions, or Clinical Trial Start‑Up within pharma, biotech, or CRO.
• Hands‑on experience with EU CTR and CTIS, including CTIS submissions and workflows.
• Solid understanding of RA, IRB/EC, and Third Body submission processes.
• Experience supporting global or regional clinical trials.

Responsibilities

• Own and manage Regulatory Authority (RA), IRB/EC, and Third Body submissions for assigned trials, including strategy, planning, and timelines.
• Lead or support EU CTR submissions via CTIS, including preparation, submission, and maintenance of CTIS applications.
• 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 and maintain up‑to‑date regulatory knowledge.

Skills

Regulatory submissions

Cross-functional collaboration

Regulatory guidance

Project management

Attention to detail

Client-facing communication

Education

Bachelor’s degree in Life Sciences or related field (or equivalent experience)

Tools

CTIS system

CTIS workflows

Job description

Fortrea is seeking a Regulatory Submissions Ass Manager II to support global and regional clinical trials through high‑quality regulatory submissions across Europe and beyond.

This role focuses on EU CTR and CTIS operations, working in a matrix, client‑facing environment with project teams, start‑up leads, local regulatory teams, and external authorities. You will ensure timely approvals and regulatory compliance.