Senior Global Regulatory Lead, Early Development

argenx; United States; Vor Ort; USD 180.000 - 240.000; Vollzeit

Benefits dieser Stelle

Short-term and long-term incentives

Zusammenfassung

argenx is seeking an Early Development Global Regulatory Lead to drive the regulatory strategy for its expanding early development portfolio in the US. You will partner with cross-functional teams to shape global regulatory pathways, interact with regulators, and ensure robust pathways from pre-nomination through early clinical development.

You will mentor the Early Development Regulatory Team, oversee filings, and help implement advanced regulatory strategies aligned with commercial goals in a

Qualifikationen

• 15+ years of regulatory affairs experience in biopharma, with 5–7 years in global leadership roles.
• Deep knowledge of regulatory strategies for FDA, EMA, and PMDA.
• Advanced scientific degree preferred (PhD or PharmD).
• Strong collaboration across functions and clear regulatory guidance.
• Experience in early and late development, including first-in-human studies.
• Ability to translate complex regulatory topics into practical business recommendations.
• Interest in applying AI and digital tools to regulatory strategy and document prep.

Aufgaben

• Provide global regulatory leadership for early development programs with clear strategy and risk alignment.
• Serve as advisor across EDRT and support accelerated, patient-centric development pathways.
• Develop and implement global regulatory strategies to meet milestones and commercial objectives.
• Ensure patient-centricity is embedded in regulatory strategy.
• Lead regulatory filings and interactions including Scientific Advice, INDs/CTAs.
• Mentor EDRT members and build cross-functional partnerships.
• Oversee regulatory affairs vendors and ensure high-quality regulator interactions.
• Collaborate with regulatory intelligence and policy teams on evolving requirements.

Kenntnisse

Global regulatory leadership

Regulatory strategy development

FDA/EMA/PMDA experience

PhD or PharmD preferred

Cross-functional collaboration

Regulatory submissions & interactions

Team leadership & mentoring

Regulatory risk assessment

Regulatory intelligence & policy

Effective communication

Ausbildung

PhD or PharmD

Jobbeschreibung

argenx is seeking an Early Development Global Regulatory Lead to drive the regulatory strategy for its expanding early development portfolio in the US. You will partner with cross-functional teams to shape global regulatory pathways, interact with regulators, and ensure robust pathways from pre-nomination through early clinical development.

You will mentor the Early Development Regulatory Team, oversee filings, and help implement advanced regulatory strategies aligned with commercial goals in a