Regulatory Submissions Ass Manager II
FortreaUnited Kingdom only
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Job Description
We are looking for a Regulatory Submissions Ass Manager II to support global and regional clinical trials through high‑quality regulatory submissions across Europe and beyond. This role plays a critical part in ensuring timely approvals, regulatory compliance, and successful study start‑up , with a strong focus on EU Clinical Trial Regulation (CTR) and CTIS operations .
You will work in a matrix, client‑facing environment , collaborating closely with project teams, start‑up leads, local regulatory teams, and external authorities.
Key Responsibilities
- Own and manage Regulatory Authority (RA), IRB/EC, and Third Body submissions for assigned clinical trials, including: