Early Development Global Regulatory Lead

🔥 14 hours ago

🌐 Belgium, Switzerland – Remote

🇧🇪 Belgium – Remote 🇨🇭 Switzerland – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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argenx

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2008

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

argenx is a biotechnology company committed to improving the lives of patients through immunology innovation. The company focuses on developing novel antibody-based therapies to treat severe autoimmune diseases. Using a collaborative approach with pioneering scientists and academic partners, argenx accelerates the discovery of therapeutic antibodies that target specific disease pathways. The company's proprietary products, such as efgartigimod, are aimed at treating diseases where IgG antibodies are pathogenic. Argenx emphasizes innovation, science of collaboration, and patient-centric approaches in its mission to deliver life-changing medical solutions.

📋 Description

• Serve as a key member of the global Early Development regulatory team • Provide global regulatory leadership for assigned early development programs • Develop regulatory strategies, identify risks, and align cross-functional teams • Implement innovative global regulatory strategies through the end of first-in-human studies • Embed patient-centricity in regulatory strategy • Represent the team in early development governance forums • Facilitate transition of programs between the early development regulatory team and asset teams • Develop infrastructure and process improvements • Mentor and coach team members • Build relationships with internal stakeholders • Monitor, interpret, and communicate evolving global regulatory requirements • Oversee regulatory affairs vendors and regulator interactions • Contribute to regulatory filings including Scientific Advice, INDs, and other requested areas

🎯 Requirements

• Minimum 15 years of regulatory affairs experience within biopharmaceutical organizations • At least 5–7 years in global leadership roles focused on major regulatory regions such as FDA, EMA, or PMDA • Strong understanding of drug development, early clinical development, first-in-human studies, orphan drugs, and regulatory strategy for innovative medicines • Proven ability to develop global regulatory strategies supporting early asset progression and regulatory interactions • Experience across early and late clinical development phases • Experience with scientific advice, IND/CTA activities, expedited pathways, and other early development regulatory milestones • Strong scientific mindset and ability to engage with scientists, clinicians, and cross-functional development teams • Complementary expertise across antibodies, peptides, siRNA, and small molecules • Experience integrating biomarker strategy, patient engagement, and patient-relevant evidence into regulatory and development plans • Strong understanding of global regulations, guidelines, regulatory expectations, and healthcare business practices • Clear and influential written, verbal, and presentation communication skills • Highly developed organizational and project management skills • Strong matrix leadership skills, relationship-building, stakeholder influence, team development, and outcome delivery • Pragmatic, creative, hands-on approach with ability to execute under challenging timelines • Candidates must be located in Belgium or Switzerland • Advanced scientific degree such as PhD or PharmD preferred

🏖️ Benefits

• Short-term incentives program eligibility • Long-term incentives program eligibility • Inclusive equal-opportunity employment environment

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