Early Development Global Regulatory Lead

🔥 5 hours ago

🇧🇪 Belgium – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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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

• Provide strategic global regulatory leadership for assigned early development programs • Develop and execute global regulatory strategies supporting expedited clinical development and First-in-Human milestones • Embed patient-focused approaches into regulatory planning and development strategies • Contribute to the Early Development Regulatory Team's growth, culture, and operational excellence • Represent Regulatory Affairs in governance committees and development forums • Partner with asset teams to transition programs from early to later development stages • Establish and enhance regulatory processes, infrastructure, and operational efficiencies • Mentor, coach, and develop regulatory organization members • Build relationships with Clinical Development, Translational Medicine, CMC, Biometrics, Medical Affairs, Commercial, and Business Development stakeholders • Monitor and communicate evolving global regulatory requirements and policies • Lead health authority interactions and oversee external regulatory vendors • Support Scientific Advice procedures, INDs, CTAs, expedited development pathways, and other regulatory activities • Contribute regulatory expertise to business development assessments, due diligence, and portfolio strategy discussions

🎯 Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Medicine, or related scientific discipline • At least 5-7 years of experience leading global regulatory strategies and teams • Deep knowledge of global regulatory frameworks, including significant experience with FDA, EMA, and PMDA • Demonstrated experience supporting innovative therapies through early clinical development, including First-in-Human studies • Proven expertise in developing and implementing global regulatory strategies • Experience conducting health authority interactions, Scientific Advice meetings, IND/CTA submissions, and expedited regulatory pathways • Strong leadership skills with the ability to influence without authority in a highly matrixed organization • Excellent verbal, written, presentation, and stakeholder management skills • Strong project management, prioritization, and organizational capabilities • Advanced scientific degree (PhD, PharmD, MD, or equivalent) preferred • Experience across both early and late-stage drug development preferred • Scientific expertise in Immunology and/or related therapeutic areas preferred • Knowledge of biologics, monoclonal antibodies, peptides, siRNA, and small molecules preferred • Experience integrating biomarker strategies, patient engagement initiatives, and patient-relevant evidence preferred • Experience supporting business development transactions, portfolio assessments, and regulatory due diligence preferred • Interest in leveraging AI-enabled and digital solutions preferred • Legal right to work in Belgium, 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