10,000+ employees
Founded 1990
đŒ Consulting
đ„ Healthcare
đŠ Logistics
Consulting âą Healthcare âą 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.
đ„ 0 minutes ago
đ Belgium, United Kingdom â Remote
â° Full Time
đĄ Mid-level
đ Senior
đ Compliance
đ» Ghost score 10%
Improve your chances of getting an interview by checking your resume score before you apply.
10,000+ employees
Founded 1990
đŒ Consulting
đ„ Healthcare
đŠ Logistics
Consulting âą Healthcare âą 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.
âą Represent Regulatory Affairs at Clinical Trial Teams (CTTs) and cross-functional meetings âą Serve as the main point of contact for clinical trials regulatory matters between argenx and partners âą Prepare, review, and coordinate regulatory submission packages, including CTAs, amendments, IBs, and IMPDs, with partners âą Ensure timely and accurate submissions in compliance with EU CTR and other regional requirements âą Monitor delegated activities and maintain oversight of regulatory deliverables âą Ensure adherence to global and local regulatory standards and company SOPs âą Liaise with Transparency Lead/Liaisons to ensure compliance with disclosure requirements âą Maintain accurate documentation and tracking of regulatory activities âą Contribute to process improvements and best practices within CTR Excellence âą Collaborate closely with Regulatory Scientists, Regulatory Coordinators, and External Partners to optimize workload
âą Bachelor's degree in a relevant scientific discipline or healthcare-related field âą Strong Regulatory submission and EU CTR experience essential âą Experience in cross-functional teams âą Strong knowledge of EU Clinical Trial Regulation (CTR) and global regulatory frameworks âą Ability to manage complex tasks, prioritize effectively, and meet tight timelines âą Attention to detail âą Effectively and proactively collaborates per operating principles to drive assignments âą Ability to interpret regulatory guidelines and apply them to operational processes âą Sound judgement and ability to analyse situations and information âą Takes decisions based on facts and figures rather than on assumptions âą Legal right to work in the country where the role is based
âą Competitive base salary and performance related incentives âą Health and wellbeing programmes including medical, dental, and vision coverage where applicable âą Retirement and pension plans âą Life assurance and disability coverage âą Employee assistance programmes and wellbeing resources âą Learning and development opportunities through structured training and career pathways
Apply Nowđ August 20
Regulatory Affairs Specialist supporting clinical-trial regulatory submissions at Worldwide Clinical Trials. Maintaining country-specific documentation and advising teams on EU-CTR and ICH GCP compliance.
đŁïžđłđ± Dutch Required
đ August 13
Regulatory Affairs Specialist managing CMC compliance for Thermo Fisher Scientificâs life-science products. Coordinating submissions, change controls, deviations, commitments, and product quality across global teams.
đ August 13
Global Regulatory Lead guiding biopharmaceutical regulatory strategy, filings, and commercialization for Thermo Fisher Scientific. Partnering with FDA, EMA, and global teams across the product lifecycle.
đ August 13
Regulatory Liaison guiding clinical-trial submissions for Thermo Fisher Scientific, a global life-sciences and healthcare services company. Ensuring EU CTR compliance, partner coordination, and regulatory deliverable oversight.
đ May 27
Regulatory and Start Up Specialist managing site activation activities in Belgium for a global clinical research firm. Ensuring compliance with regulations while serving as a Single Point of Contact for sites and project teams.
đ§đȘ Belgium â Remote
đ° $1G Post-IPO Debt on 2023-05
â° Full Time
đĄ Mid-level
đ Senior
đ Compliance
đŁïžđłđ± Dutch Required
đŁïžđ«đ· French Required