P2624 - Global Regulatory Affairs Specialist/Manager

Position

Vollzeit

Festanstellung

Mid

Konditionen

Lausanne, Switzerland

100%

Anforderungen

4+ J. Erfahrung

Bachelor

EU/EFTA-Bewilligung

Sprachen

Englisch C1

Französisch

Beschreibung

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.

Aufgaben

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.
Act as the Regulatory Affairs representative on cross-functional sub-teams.
Partner with functional experts to coordinate seamless input into regulatory documentation.
Actively participate in the review of key regulatory-relevant documents.
Maintain up-to-date knowledge of the global competitive and regulatory landscape.
Contribute to establishing and revising Standard Operating Procedures (SOPs).

Anforderungen

Bachelor’s degree in Life Sciences; an advanced degree (Master's/PhD) is preferred.
Minimum of 4 years of regulatory affairs experience within R&D drug development.
Solid understanding of EU and/or US regulatory procedures.
Independent, results-driven, agile, and team-oriented.
Excellent communication, time management, and analytical skills.
Proficiency in oral and written English is required; knowledge of French is an asset.

Vorteile

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.

Unternehmen

Debiopharm

Biopharmaceuticals

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.