Regulatory CMC Coordinator

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🔥 0 minutes ago

🌐 United Kingdom, Poland – Remote

🇬🇧 United Kingdom – Remote 🇵🇱 Poland – 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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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Support the compilation, maintenance, and quality control of CMC regulatory submission documentation, including IMPDs, Module 2.3 and Module 3 content, and Clinical Trial Application (CTA) submissions • Prepare, track, and maintain CMC submission plans, manufacturing data, response documents, forms, cover letters, and supporting submission materials within regulatory systems • Ensure regulatory documents are maintained in an electronic submission-ready format and support the preparation of submission packages and associated documentation • Create and maintain regulatory records, master and country-specific IMPD binders, GMP certificates, Manufacturing Import Authorizations (MIAs), and related compliance documentation • Support the review and reconciliation of regulatory data, dossier information, submission trackers, and metadata across systems • Coordinate with Regulatory CMC Leads, Regulatory Operations, and cross-functional stakeholders to facilitate workflow reviews, approvals, and regulatory updates • Assist with regulatory information management activities within RIM platforms, supporting compliance with internal processes and regulatory requirements

🎯 Requirements

• Bachelor's degree in Life Sciences or a related scientific discipline • Experience supporting regulatory submissions, Clinical Trial Applications (CTAs), CMC activities, or regulatory operations within the pharmaceutical, biotechnology, or CRO industry • Knowledge of regulatory documentation, including IMPDs, GMP documentation, and electronic submission processes • Experience working with electronic document management or regulatory information management systems such as Veeva RIM or similar platforms • Strong organizational, communication, and data management skills, with the ability to manage multiple activities while maintaining a high level of accuracy • Knowledge of eCTD requirements, document publishing standards, or electronic submission environments (preferred) • Experience working with regulatory databases, submission tracking tools, and regulatory information management systems (preferred) • Comfortable working in AI-enabled environments and leveraging technology to improve operational efficiency (preferred) • Legal right to work in the country where the role is based

🏖️ Benefits

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways