P2626 - Global Programme Regulatory Manager

• 11 août 2026 • Indefinite duration • Lausanne *Together, we innovate, we impact, we grow!* ### *At Debiopharm, every step we take is guided by a single goal: to improve the lives of people affected by cancer and infectious diseases. As a private Swiss biopharmaceutical company, we are driven by science, but above all by the people behind every treatment - the patients and their families.* *Through our unique “development only” model, we advance promising therapies and transform them into treatments that can more quickly reach those who need them most.* Are you ready to pave the regulatory way to bring life-saving therapies to patients more quickly?   We are currently looking for a dynamic Global Programme Regulatory Manager to shape the future of our pipeline. In this key role, you will be the strategic regulatory voice within project teams, defining global regulatory strategies for innovative medicines - including small molecules, biologics, and radiopharmaceuticals - from first-in-human studies to registration. Your mission is to maximize the value of compounds, navigate complex global regulatory environments, and accelerate early access for patients with significant unmet medical needs. This position is part of the Regulatory Affairs team and will be based at our headquarters in Lausanne, Switzerland.   Global Programme Regulatory Manager ### Permanent position, full-time | Lausanne, Switzerland Executive Summary of Responsibilities As Global Programme Regulatory Manager, you are responsible for defining, developing, and executing end-to-end global regulatory strategies for assigned development projects. Reporting to the Head of Regulatory Affairs, you will be the main interface with health authorities (FDA, EMA, and others), lead cross-functional regulatory sub-teams, support commercial development opportunities, and mentor junior regulatory professionals to ensure operational excellence and compliance. Key Tasks and Responsibilities • Strategic Regulatory Leadership: Develop and implement end-to-end global regulatory strategies for innovative drug projects covering preclinical, clinical, and registration phases. • Interaction with Health Authorities: Act as the primary interface for key regulatory agencies (FDA, EMA, etc.), coordinate and lead meetings and negotiations with these agencies. • Global Submissions: Responsible for major global submissions including INDs/CTAs, briefing documents, orphan drug designations, PIP/PSPs, and accelerated pathways (Fast Track, Breakthrough, PRIME). • Cross-functional Governance: Represent Regulatory Affairs within project and clinical study teams, present and defend strategic plans to internal governance bodies. • Document Ownership: Review, approve, and coordinate expert contributions for crucial deliverables such as clinical study protocols, clinical study reports, statistical plans, and periodic safety reports. • Commercial Development & Monitoring: Support in-licensing assessments and out-licensing teams while monitoring the competitive and regulatory landscape to mitigate impacts on projects. • Vendor & Sub-team Supervision: Lead matrixed regulatory sub-teams and manage external regulatory vendors/CROs to ensure high-quality execution. • Process Excellence: Strive to continuously optimize processes within Regulatory Affairs and cross-functionally, including contributing to SOP management. • People Management: Manage, coach, and contribute to the development of junior members of the regulatory team. Required Profile • Education: Bachelor's degree in life sciences; a Master's or PhD/PharmD is strongly preferred. • Regulatory Expertise: More than 10 years of experience in regulatory affairs for innovative medicines, preferably in oncology or anti-infectives, with in-depth knowledge of the global drug development process; experience with regulatory strategies from first-in-human studies through to Phase 3 design and registration is a major asset. • Agency Engagement: Proven experience in direct conduct of meetings with regulatory agencies (US & EU experience required; other global markets an asset). • Submission Experience: Demonstrated success in leading cross-functional teams for the preparation of major regulatory deliverables, accelerated pathways, and global clinical trial applications. • Matrix Leadership: Strong ability to lead cross-functional sub-teams and influence outcomes in a matrix organization with agility and determination. • Problem Solving & Autonomy: Independent, results-oriented professional, capable of innovating, analyzing, and resolving critical regulatory challenges with minimal supervision. • BD & Lifecycle Knowledge: Familiarity with commercial development assessments (in/out-licensing) as well as lifecycle management or innovative formulation strategies. • Communication & Languages: Excellent organizational and communication skills in English; proficiency or good knowledge of French is a distinct advantage. What We Offer • Being part of a company where innovation, collaboration, and impact are not just values - it is our way