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Regulatory Submissions Ass Manager II

Fortrea347 open roles

Where
Leeds
Work mode
Remote
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Your applicationOpen nowRegulatory Submissions Ass Manager IIFortrea · Leeds

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The clock on this job

Early applications get read.

10.5% of postings close within 7 days. Measured by our own scanner across the market. Fortrea postings stay open a median of 7 days.

Share of postings closed within
  1. 2.1%1 day
  2. 4.3%3 days
  3. 10.5%7 days
  4. 15.9%14 days
  5. 34.1%30 days
This job: posted today

Fortrea median: 7 days open

The posting

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:Submission strategy, planning, and timeline management Tracking approvals against project milestones (GL, RTE) Coordinating responses to authority queries within defined timelines
  • Lead or support EU CTR submissions via CTIS, including:Preparation, submission, and maintenance of CTIS applications Managing CTIS user access and acting as CTIS back‑up when required Advising internal teams on CTR/CTIS processes and expectations
  • Prepare, review, and quality‑check core regulatory packages and country‑specific submission packages
  • Ensure all deliverables comply with applicable regulations, guidance, SOPs, and client requirements
  • Provide regulatory guidance to project teams 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 overall team capability building

Required Qualifications & Experience

  • Bachelor’s degree in Life Sciences or a 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 is required, including:Preparing and submitting applications in CTIS Managing CTIS workflows, timelines, and user access Responding to CTIS‑related authority questions
  • Solid understanding of RA, IRB/EC, and Third Body submission processes
  • Experience supporting global or regional clinical trials
  • Strong organizational skills with the ability to manage multiple submissions and deadlines
  • Confident communicator able to work with cross‑functional and client stakeholders

Learn more about our EEO & Accommodations request here.

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