Senior Global Regulatory Scientist

🔥 0 minutes ago

🌐 Ireland, Poland, +1 more countries – Remote

🇮🇪 Ireland – Remote 🇵🇱 Poland – Remote 🇧🇬 Bulgaria – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

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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

• Lead the development of global regulatory strategies for clinical programmes, including plans for key health authority interactions and milestones • Author and review complex regulatory documents such as clinical trial applications and major submission components • Interpret evolving global regulations, guidelines, and precedents, and advise teams on implications for programme design and execution • Provide strategic input into clinical development plans, risk management strategies, and labelling considerations • Represent regulatory functions in sponsor and health authority meetings • Mentor junior regulatory colleagues • Contribute to internal best practices, templates, and knowledge-sharing initiatives

🎯 Requirements

• Bachelor's degree in a relevant scientific discipline or healthcare-related field • Extensive experience in regulatory affairs or regulatory science within pharma, biotech, or CRO environments • Strong knowledge of global clinical development regulations, including FDA, EMA, and ICH, and regional requirements • Excellent scientific, analytical, and critical-thinking skills • Ability to integrate complex data into regulatory positions • Outstanding written and verbal communication abilities • Meticulous attention to detail • Proven experience interacting with health authorities • Proven experience leading cross-functional regulatory projects • Willingness to travel as required, approximately 10% • 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 • Home working option