P2624 - Global Regulatory Affairs Specialist/Manager

Debiopharm seeks a Global Regulatory Affairs Specialist/Manager in Lausanne to drive regulatory strategies for innovative medicines from early clinical stages through to registration.

This position plays a key role in supporting the development of new therapies, including small molecules, biologics, and radiopharmaceuticals. The specialist contributes to regulatory strategies ranging from First-in-human studies to final registration, ensuring that all activities comply with applicable regulations and internal processes.

Responsibilities

• Create and execute global regulatory affairs strategies for designated projects.
• Oversee external partners, including Contract Research Organizations (CROs).
• Prepare and monitor regulatory submissions across multiple regions, such as INDs/CTAs, Briefing Documents, Orphan Drug Applications, PIP/PSP, and designations like Fast Track or PRIME.
• Act as the regulatory affairs representative within cross-functional groups, including Clinical Trial Teams.
• Review regulatory-relevant documents, including Clinical Study Protocols, Clinical Study Reports, and DSURs.
• Collaborate with functional experts to coordinate their inputs for regulatory documentation.
• Stay informed about the global competitive and regulatory landscape to assess how changes may impact assigned projects.
• Help establish and update standard operating procedures to improve process efficiency and ensure regulatory compliance.

Requirements

• Bachelor of Science degree in Life Sciences.
• Minimum of three years of experience in regulatory affairs within drug development, including managing clinical trials.
• Clear understanding of regulatory procedures in the EU and/or US.
• Strong proficiency in English, both spoken and written.

Nice to have

• Advanced degree beyond the BSc.
• Knowledge of the French language.

What the company offers

• Join a company where innovation, collaboration, and impact are central to daily operations.
• Collaborate with multidisciplinary teams focused on oncology and anti-infective development.
• Work in an inclusive and respectful environment, recognized by Equal-Pay certification.
• Develop professionally in a culture that prioritizes people, purpose, and performance.
• Contribute to shaping the future of healthcare through growth and shared expertise.

About the company

Debiopharm fosters an inclusive and respectful workplace where innovation, collaboration, and impact are core working principles. The company is Equal-Pay certified and builds its culture around people, purpose, and performance.

• Innovation, collaboration, and impact are central to how the company works.
• The workplace is inclusive and respectful.
• The company holds Equal-Pay certification.
• Culture emphasizes people, purpose, and performance.