Global Early Development Regulatory Leader

Argenx; Zürich; In loco; CHF 230.000 - 310.000; Tempo pieno

Descrizione del lavoro

argenx seeks an Early Development Global Regulatory Lead to drive global regulatory strategy for its early development portfolio. You will partner with scientific and clinical teams to shape development plans and interactions with regulators, ensuring robust foundations for onward progression.

The role demands senior leadership across regulatory affairs, with a focus on early clinical development, scientific advice, and IND/CTA activities while aligning with argenx’s patient-centric goals and

Competenze

• 15+ years of regulatory affairs experience in biopharma
• Experience in global leadership roles with FDA/EMA/PMDA focus
• Experience in early clinical development and regulatory strategy

Mansioni

• Serve as global regulatory lead for assigned early development programs
• Develop and implement global regulatory strategies
• Mentor EDRT members and build regulatory partnerships
• Collaborate with cross-functional teams to enable expedited development

Conoscenze

Global regulatory leadership

Regulatory strategy

IND/CTA experience

Cross-functional collaboration

Regulatory authorities interaction

Orphan drug/regulatory strategy

People leadership

Drug development knowledge

Formazione

PhD or PharmD

Descrizione del lavoro

argenx seeks an Early Development Global Regulatory Lead to drive global regulatory strategy for its early development portfolio. You will partner with scientific and clinical teams to shape development plans and interactions with regulators, ensuring robust foundations for onward progression.

The role demands senior leadership across regulatory affairs, with a focus on early clinical development, scientific advice, and IND/CTA activities while aligning with argenx’s patient-centric goals and