P2624 - Global Regulatory Affairs Specialist/Manager

Together, we innovate, we impact, we grow! At Debiopharm, every step we take is guided by one purpose: improving the lives of people affected by cancer and infectious diseases. As a privately-owned Swiss biopharmaceutical company, we're driven by science, but above all, by the people behind every treatment - the patients and their families.

Through our unique "development-only" model, we bring forward promising therapies and transform them into treatments that can reach those who need them most, faster.

We are currently seeking a dedicated professional to join our Regulatory Affairs team in Lausanne, Switzerland. In this role, you will support the development of innovative new medicines, including small molecules, biologics, and radiopharmaceuticals, helping to define paths that enable early access to patients with high unmet medical needs, as a:

Global Regulatory Affairs Specialist/ManagerPermanent role, Full-time | Location: Lausanne, Switzerland

Your Mission:Reporting to the Program Lead Global Regulatory Affairs, your primary goal is to bring technical and operational expertise toward global regulatory strategies from First-In-Human studies through to registration. Working in a matrix environment, you will collaborate closely across cross-functional teams to maximize compound value, ensure regulatory compliance, and navigate global competitive landscapes.

Key Responsibilities:· Strategy & Submissions: Support senior team members in developing and executing global regulatory strategies. Assist in managing external vendors (e.g., CROs) and preparing/tracking multi-jurisdictional filings (INDs/CTAs, Briefing Documents, Orphan Drug Applications, PIP/PSP, Fast Track, Breakthrough Designation, PRIME, etc.). · Cross-Functional Collaboration: Act as the Regulatory Affairs representative on cross-functional sub-teams, including Clinical Study Teams. Partner with functional experts to coordinate seamless input into regulatory documentation. · Document Review: Actively participate in the review of key regulatory-relevant documents, such as Clinical Study Protocols, Clinical Study Reports, DSURs, and related filings. · Landscape Assessment: Maintain up-to-date knowledge of the global competitive and regulatory landscape, evaluating the potential impact of changes on assigned projects. · Process Excellence: Contribute to establishing and revising Standard Operating Procedures (SOPs) to enhance process efficiency and ensure ongoing regulatory compliance.