Early Development Global Regulatory Lead

• 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

• 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

• 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