Early Development Global Regulatory Lead

argenx seeks an Early Development Global Regulatory Lead to direct regulatory strategy and governance for its expanding early-stage pipeline. This role provides strategic oversight of early clinical programs, from pre-nomination through first-in-human studies, and mentors the regulatory team while partnering cross-functionally to accelerate patient-centric development pathways.

Responsibilities

• Lead global regulatory strategy and risk identification for assigned early-stage development programs
• Co-create and implement innovative regulatory pathways to support expedited development milestones
• Represent the Early Development Regulatory Team in governance forums and ensure timely stakeholder alignment
• Mentor and develop regulatory team members and oversee vendor relationships with regulators
• Contribute directly to regulatory filings including Scientific Advice requests, INDs, and related submissions

Requirements

• Minimum 15 years regulatory affairs experience in biopharmaceutical organizations
• At least 5–7 years in global leadership roles covering FDA, EMA, or PMDA
• Advanced degree preferred: PhD or PharmD
• Direct experience in early clinical development, first-in-human studies, and orphan drug strategy
• Proven ability to develop and execute global regulatory strategies for innovative assets
• Strong scientific mindset with credibility engaging scientists, clinicians, and cross-functional teams
• Immunology expertise highly desirable; familiarity with antibodies, peptides, siRNA, and small molecules