Senior Global Regulatory Leader, Early Development

argenx US; Oost-Vlaanderen; On-site; EUR 120,000 - 180,000; Full time

Job summary

argenx is expanding its regulatory team and seeks an Early Development Global Regulatory Lead to drive global regulatory strategies for its early development portfolio, including first-in-human studies and orphan indications.

The role partners with cross-functional teams and regulators to accelerate patient access, ensure robust regulatory foundations, and guide programs from pre-nomination through early clinical development and regulatory interactions.

Qualifications

• Minimum 15 years of regulatory affairs experience in biopharma, with 5–7 years in global leadership roles (FDA/EMA/PMDA).
• Experience in early development, first-in-human studies, and orphan drugs.
• Experience with regulatory strategy, scientific advice, IND/CTA activities, and expedited pathways.

Responsibilities

• Provide global regulatory leadership for assigned early development programs.
• Co-create and implement global regulatory strategies to deliver expedited milestones.
• Ensure patient-centric regulatory strategy across development.
• Interact with regulatory authorities for scientific advice and regulatory submissions (IND/CTA).
• Oversee regulatory filings and vendor interactions; mentor EDRT members.

Skills

Global regulatory leadership

Regulatory strategy

Cross-functional collaboration

Regulatory filings

Stakeholder management

Education

PhD or PharmD preferred

Job description

argenx is expanding its regulatory team and seeks an Early Development Global Regulatory Lead to drive global regulatory strategies for its early development portfolio, including first-in-human studies and orphan indications.

The role partners with cross-functional teams and regulators to accelerate patient access, ensure robust regulatory foundations, and guide programs from pre-nomination through early clinical development and regulatory interactions.