Global Program Regulatory Lead

About the role

Debiopharm is seeking a Global Program Regulatory Lead to define and execute regulatory strategies for innovative medicines across the full development lifecycle, from first‑in‑human studies to registration.

Key responsibilities

• Develop and implement end‑to‑end global regulatory strategies for assigned projects.
• Lead interactions with health authorities (FDA, EMA, etc.) and coordinate agency meetings.
• Oversee global submissions including INDs/CTAs, orphan drug designations, PIP/PSPs, and expedited pathways.
• Represent Regulatory Affairs on project and clinical study teams and ensure regulatory compliance of key documents.
• Mentor junior regulatory professionals and manage external vendors/CROs.

Required profile

• 10+ years of regulatory affairs experience in innovative medicines, preferably oncology or anti‑infectives.
• Proven track record of leading meetings with FDA and EMA.
• Strong matrix leadership and ability to influence cross‑functional teams.
• Excellent communication skills in English; French is a distinct advantage.

Required skills

• Regulatory strategy development across preclinical, clinical and registration phases.
• Preparation of major regulatory deliverables (IND, CTA, briefing documents, orphan designations, etc.).

What we offer

• Opportunity to work on cutting‑edge oncology and anti‑infective programs.
• Inclusive, equal‑pay certified workplace with strong collaboration culture.