Regulatory Submissions Manager II

🔥 2 hours ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• Own and manage Regulatory Authority (RA), IRB/EC, and Third Body submissions for assigned clinical trials • Develop submission strategy, planning, and timeline management • Track approvals against project milestones (GL, RTE) • Coordinate responses to authority queries within defined timelines • Lead or support EU CTR submissions via CTIS • Prepare, submit, and maintain CTIS applications • Manage CTIS user access and act as CTIS back-up when required • Advise internal teams on CTR/CTIS processes and expectations • Prepare, review, and quality-check core and country-specific regulatory submission packages • Ensure deliverables comply with applicable regulations, guidance, SOPs, and client requirements • Provide regulatory guidance 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 team capability building

🎯 Requirements

• 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 • Experience preparing and submitting applications in CTIS • Experience managing CTIS workflows, timelines, and user access • Experience 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 communication and ability to work with cross-functional and client stakeholders