P2624 Global Regulatory Affairs SpecialistManager

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 were 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 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:

Permanent role Full-time Location: Lausanne Switzerland

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.

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.

Education: Bachelors degree in Life Sciences; an advanced degree (Masters/PhD) is preferred.

Experience: Minimum of 4 years of regulatory affairs experience within R&D drug development including hands-on experience managing clinical trials.

Regulatory Expertise: Solid understanding of EU and/or US regulatory procedures.

Drive and Mindset Independent results-driven agile and team-oriented with a proven ability to influence outcomes.

Organization and Working Style : Excellent communication time management and analytical skills equipped with a solution-driven approach to manage multiple tasks simultaneously.

Languages: Proficiency in oral and written English is required; knowledge of French is an asset.

• Being part of a company where innovation collaboration and impactarentjust values theyrehow we work every day

• Partner with teams across disciplines at the forefront of oncology and anti-infective development

• An inclusive and respectful workplace proud to be Equal-Pay certified

• Grow in a culture that values people purpose and performance

• A chance to grow share and shape the future of healthcare

If your application is selectedyoullbe invited to interviews with Talent Acquisition and the Hiring Manager via Teams followed by apanelinterview and reference checks. Communication is handled via Workablecheck your spam folder for emails from*@.

We do not accept unsolicited applications from agencies or recruiters.

Required Experience:

Manager