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, SwitzerlandYour 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.RequirementsYour Profile:· Education: Bachelor’s degree in Life Sciences; an advanced degree (Master's/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.Skills & Core Competencies :· 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.BenefitsWhat we Offer: Being part of a company where innovation, collaboration, and impact aren’t just values — they’re how 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 What to Expect in the Recruitment Process: If your application is selected, you’ll be invited to interviews with Talent Acquisition and the Hiring Manager via Teams, followed by a panel interview and reference checks. Communication is handled via Workable—check your spam folder for emails from *@outbound.workable.com. We do not accept unsolicited applications from agencies or recruiters.

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/Manager

Permanent 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.

Requirements

Your Profile:

· Education: Bachelor’s degree in Life Sciences; an advanced degree (Master's/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.

Skills & Core Competencies :

· 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.

Benefits

What we Offer:

• Being part of a company where innovation, collaboration, and impact aren’t just values — they’re how 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

What to Expect in the Recruitment Process:

If your application is selected, you’ll be invited to interviews with Talent Acquisition and the Hiring Manager via Teams, followed by a panel interview and reference checks. Communication is handled via Workable—check your spam folder for emails from *@outbound.workable.com.

We do not accept unsolicited applications from agencies or recruiters.

Debiopharm is an independent biopharmaceutical company based in Switzerland with headquarters in Lausanne(VD) and a manufacturing site in Martigny (VS).We are committed to developing innovative therapies that target high unmet medical needs in oncology and infectious diseases with a broad range of expertise in drug development, drug manufacturing as well as investment in start-ups. Through our unique business model, we identify high-potential compounds and technologies for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.

Debiopharm is an independent biopharmaceutical company based in Switzerland with headquarters in Lausanne(VD) and a manufacturing site in Martigny (VS).

We are committed to developing innovative therapies that target high unmet medical needs in oncology and infectious diseases with a broad range of expertise in drug development, drug manufacturing as well as investment in start-ups.

Through our unique business model, we identify high-potential compounds and technologies for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.