Senior Manager, Regulatory Affairs

Job not on LinkedIn

🔥 3 minutes ago

🌐 Belgium, Germany, +4 more countries – Remote

🇧🇪 Belgium – Remote 🇩🇪 Germany – Remote 🇵🇱 Poland – Remote 🇪🇸 Spain – Remote 🇬🇧 United Kingdom – Remote 🇮🇪 Ireland – Remote

⏰ Full Time

🟠 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

• 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 • Participate in regulatory affairs activities across the ICON portfolio • Advise ICON clients, both externally and internally • Represent the Regulatory Affairs Department in business development activities • Generate new business opportunities • Contribute to interactions with regulatory agencies, early phase consulting, development planning, scientific/agency advice, orphan drugs/pediatric development, or medical devices

🎯 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 • Pharmaceutical/CRO industry experience • US/LATAM/CAN: A minimum of 7 years regulatory affairs experience including supervisory experience and a minimum of 6 years pharmaceutical/CRO industry • Demonstrable experience within regulatory affairs, 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 and problem-solving ability • Strong interpersonal skills and ability to plan/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