Global Regulatory Lead – Oncology & Infectious Diseases

Debiopharm; Lausanne; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Benefits dieser Stelle

Equal-Pay certified

Zusammenfassung

Debiopharm in Lausanne, Switzerland, seeks a Global Program Regulatory Lead to shape regulatory strategy across oncology and infectious disease programs from first-in-human through registration.

You will lead interactions with health authorities, coordinate cross-functional teams, oversee submissions and ensure compliant development, with a focus on accelerating access to patients in need.

Qualifikationen

• Bachelor’s degree in life sciences; Master’s or PhD/PharmD preferred.
• 10+ years of regulatory affairs experience for innovative medicines.
• Experience leading meetings with regulatory agencies (US & EU experience required).

Aufgaben

• Define and execute end-to-end global regulatory strategies.
• Lead agency meetings and negotiations.
• Manage global submissions including INDs/CTAs and DSURs.
• Represent Regulatory Affairs on cross-functional teams and governance.
• Oversee deliverables like CSRs, SAPs, and other regulatory documents.
• Support in- and out-licensing evaluations.

Kenntnisse

Regulatory affairs

Project leadership

Communication

English fluency

French knowledge

Ausbildung

Bachelor's in life sciences

Master/PhD/PharmD preferred

Jobbeschreibung

Debiopharm in Lausanne, Switzerland, seeks a Global Program Regulatory Lead to shape regulatory strategy across oncology and infectious disease programs from first-in-human through registration.

You will lead interactions with health authorities, coordinate cross-functional teams, oversee submissions and ensure compliant development, with a focus on accelerating access to patients in need.