Description du poste
Debiopharm est une entreprise biopharmaceutique suisse dédiée à l’oncologie. Rejoignez un environnement innovant et respectueux, axé sur l’impact.TâchesCoordonner les activités réglementaires CMC pour plusieurs projets.Rédiger et examiner des documents réglementaires de haute qualité.Collaborer avec des équipes interfonctionnelles pour guider les soumissions.CompétencesMaster en biologie, biotechnologie ou équivalent requis.Connaissance des cadres réglementaires CMC globaux.Excellentes compétences en collaboration et en communication.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.If you’re ready to make a real impact — this is your moment.Join us at our Headquarters in Lausanne, Switzerland as a:Senior Scientist, CMC Regulatory Affairs (100%)Our CMC Team is looking for Senior Scientist to lead and coordinate CMC regulatory activities across multiple development projects—including small molecules, biologics (ADCs), and radiopharmaceuticals. You’ll be the cornerstone for delivering high-quality CMC documentation to support clinical trial applications (Phase 1 to Phase 3), due diligences, and licensing opportunities.Your Mission.Propose and execute CMC regulatory strategies tailored to each project’s needsLead the drafting, and review of CMC sections in regulatory submissions (IMPDs, INDs)Serve as the CMC-RA representative in cross-functional teams, guiding dossier preparation and providing expert input throughout developmentMaintain oversight tools (document trackers, risk assessments, deliverables) to ensure efficient coordination and timely deliveryCollaborate with Regulatory Affairs on submission strategy and responses to Health AuthoritiesManage a network of CMC-RA consultants and vendors, ensuring quality and alignment with project objectivesReview and finalize externally drafted regulatory documents, maintaining full compliance and scientific clarityMore than a checklist of skills, we’re looking for someone who shares our commitment to science with purpose.Master’s degree in biology, molecular biology, biotechnology, biochemistry, or pharmacistSolid knowledge of global CMC regulatory frameworks (EU, US, ICH), with experience acrosssmall molecules, biologics (ADCs), and radiopharmaceuticals.Proven ability to draft, review, and finalize high-quality regulatory documents.Strong grasp of pharmaceutical development processes—from drug substance to drug product, including formulation and manufacturing.High attention to detail and strong organizational skills to manage priorities across projects.Experience with document management systems (e.g., Veeva) is a plus.Team-oriented mindset and excellent collaboration skills with CMC, RA, QA, and external partnersAnalytical and systematic working styleFluent in English and French.Being part of a company where innovation, collaboration, and impact aren’t just values — they’re how we work every dayPartner with teams across disciplines, at the forefront of oncology and anti-infective developmentAn inclusive and respectful workplace — proud to be Equal-Pay certifiedGrow in a culture that values people, purpose, and performanceA chance to grow, share, and shape the future of healthcareWhat 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.Please contact our HR Department prior to submitting any profiles. We cannot accept unsolicited applications from agencies or recruiters. Lire la suite
