Regulatory Liaison

Job not on LinkedIn

đŸ”„ 0 minutes ago

🌐 Belgium, United Kingdom – Remote

infoinfo

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

đŸ‘» Ghost score 10%

infoinfo
Apply Now
Find Similar Remote Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Logo of ICON plc

ICON plc

10,000+ employees

Founded 1990

đŸ’Œ Consulting

đŸ„ 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

‱ Represent Regulatory Affairs at Clinical Trial Teams (CTTs) and cross-functional meetings ‱ Serve as the main point of contact for clinical trials regulatory matters between argenx and partners ‱ Prepare, review, and coordinate regulatory submission packages, including CTAs, amendments, IBs, and IMPDs, with partners ‱ Ensure timely and accurate submissions in compliance with EU CTR and other regional requirements ‱ Monitor delegated activities and maintain oversight of regulatory deliverables ‱ Ensure adherence to global and local regulatory standards and company SOPs ‱ Liaise with Transparency Lead/Liaisons to ensure compliance with disclosure requirements ‱ Maintain accurate documentation and tracking of regulatory activities ‱ Contribute to process improvements and best practices within CTR Excellence ‱ Collaborate closely with Regulatory Scientists, Regulatory Coordinators, and External Partners to optimize workload

🎯 Requirements

‱ Bachelor's degree in a relevant scientific discipline or healthcare-related field ‱ Strong Regulatory submission and EU CTR experience essential ‱ Experience in cross-functional teams ‱ Strong knowledge of EU Clinical Trial Regulation (CTR) and global regulatory frameworks ‱ Ability to manage complex tasks, prioritize effectively, and meet tight timelines ‱ Attention to detail ‱ Effectively and proactively collaborates per operating principles to drive assignments ‱ Ability to interpret regulatory guidelines and apply them to operational processes ‱ Sound judgement and ability to analyse situations and information ‱ Takes decisions based on facts and figures rather than on assumptions ‱ Legal right to work in the country where the role is based

đŸ–ïž 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

Apply Now

Similar Jobs

🕒 August 20

Worldwide Clinical Trials

1001 - 5000

đŸ„ Healthcare

đŸ’Œ Consulting

📩 Logistics

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.

đŸ—ŁïžđŸ‡łđŸ‡± Dutch Required

🕒 August 13

Thermo Fisher Scientific

10,000+ employees

đŸ„ Healthcare

📩 Logistics

🏭 Manufacturing

Regulatory Affairs Specialist managing CMC compliance for Thermo Fisher Scientific’s life-science products. Coordinating submissions, change controls, deviations, commitments, and product quality across global teams.

🕒 August 13

Thermo Fisher Scientific

10,000+ employees

đŸ„ Healthcare

📩 Logistics

🏭 Manufacturing

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.

🕒 August 13

Thermo Fisher Scientific

10,000+ employees

đŸ„ Healthcare

📩 Logistics

🏭 Manufacturing

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.

🕒 May 27

IQVIA

10,000+ employees

đŸ’Œ Consulting

🏭 Manufacturing

📣 Marketing

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.

đŸ—ŁïžđŸ‡łđŸ‡± Dutch Required

đŸ—ŁïžđŸ‡«đŸ‡· French Required