P2626 - Global Program Regulatory Lead

Debiopharm, a privately‑owned Swiss biopharmaceutical company focused on cancer and infectious disease therapies, is seeking a Global Program Regulatory Lead. The position sits within the Regulatory Affairs team at the Lausanne headquarters and serves as the strategic regulatory voice for innovative drug programs, ranging from small molecules to biologics and radiopharmaceuticals, from first‑in‑human studies through registration. In this role you will design and execute comprehensive global regulatory strategies, act as the main liaison with agencies such as the FDA and EMA, and steer key submissions including INDs, CTAs, orphan‑drug designations and accelerated‑pathway applications. You will represent Regulatory Affairs on project and clinical study teams, review and approve critical documents like protocols and CSR reports, and oversee external vendors and CROs. Additionally, you will mentor junior regulators, contribute to SOP improvement, and support business‑development assessments for in‑ and out‑licensing opportunities. The position requires a bachelor’s degree in life sciences, with a master’s, PhD or PharmD strongly preferred, and at least ten years of regulatory affairs experience in innovative medicines, ideally oncology or anti‑infectives. Candidates must have a proven record of leading meetings with US and EU regulators, delivering major cross‑functional regulatory deliverables, and managing matrixed teams. Fluency in English is essential, while working knowledge of French is considered an advantage. A French‑speaking environment in Lausanne, an inclusive workplace certified for equal pay, and the chance to collaborate across disciplines in a fast‑moving pipeline are highlighted as attractive aspects. The role offers the opportunity to influence early patient access and to grow within a culture that values purpose, performance and continuous improvement.