Global Regulatory Lead, Early Development

Argenx; Oost-Vlaanderen; On-site; EUR 150,000 - 190,000; Full time

Benefits offered by this job

Incentives program

Global exposure

Job summary

argenx is seeking an Early Development Global Regulatory Lead to steer regulatory strategy for its early development portfolio. The role partners with cross-functional teams to deliver expedited, patient-centric development plans and to ensure alignment with global regulatory expectations.

The candidate will provide high-quality regulatory input from pre-nomination through first-in-human studies, manage interactions with authorities, and mentor the Early Development Regulatory Team within a

Qualifications

• Minimum 15 years in regulatory affairs within biopharma
• 5–7+ years in global leadership roles (FDA/EMA/PMDA)
• Strong scientific background with immunology focus

Responsibilities

• Provide global regulatory leadership for early development programs
• Co-create and implement global regulatory strategies to accelerate milestones
• Interact with authorities for scientific advice and IND/CTA activities
• Mentor and coach EDRT members and engage cross-functional teams

Skills

Global regulatory leadership

Regulatory strategy development

Scientific advice & IND/CTA

Cross-functional collaboration

Regulatory intelligence & policy

Education

PhD or PharmD

Tools

Regulatory submissions

Job description

argenx is seeking an Early Development Global Regulatory Lead to steer regulatory strategy for its early development portfolio. The role partners with cross-functional teams to deliver expedited, patient-centric development plans and to ensure alignment with global regulatory expectations.

The candidate will provide high-quality regulatory input from pre-nomination through first-in-human studies, manage interactions with authorities, and mentor the Early Development Regulatory Team within a