Senior Manager, Regulatory Affairs

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🌐 Belgium, Hungary, +7 more countries – Remote

🇧🇪 Belgium – Remote 🇭🇺 Hungary – Remote 🇪🇸 Spain – Remote 🇧🇬 Bulgaria – Remote 🇷🇴 Romania – Remote 🇩🇪 Germany – Remote 🇵🇱 Poland – Remote 🇮🇹 Italy – Remote 🇮🇪 Ireland – 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

• Oversee regulatory affairs delivery • Coach the regulatory affairs team • Drive continuous improvement • Provide regulatory expertise in strategic drug development across multiple areas • Participate in preparation of strategic development and submission plans • Contribute to regulatory affairs activities across the ICON portfolio • Serve as an expert and advisor to ICON clients, externally and internally • Represent the Regulatory Affairs Department in business development activities • Generate new business opportunities • Contribute to at least two areas including regulatory agency interactions, early phase consulting, development planning, scientific/agency advice, orphan drugs/pediatric development, and medical devices • Design and analyse clinical trials, interpret complex medical data, and contribute to innovative treatments and therapies

🎯 Requirements

• Bachelor's degree in a relevant scientific discipline or healthcare-related field • EU/APAC: In-depth proven regulatory affairs expertise • Minimum of 7 years' experience and supervisory experience for EU/APAC roles • Pharmaceutical/CRO industry experience for EU/APAC roles • US/LATAM/CAN: Minimum of 7 years regulatory affairs experience including supervisory experience • US/LATAM/CAN: Minimum of 6 years pharmaceutical/CRO industry experience • Demonstrable regulatory affairs experience, including development of regulatory strategies, document writing, marketing authorization applications, clinical trials, post-licensing activities, and direct regulatory agency interaction • Strong organizational skills and ability to manage multiple tasks • Meticulous attention to detail • Excellent written, verbal, and management skills • Demonstrated presentation skills • Problem-solving ability and strong interpersonal skills • Ability to plan and organize • 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

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