P2513 - Senior Scientist, CMC Regulatory Affairs

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 needs
• Lead 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 development
• Maintain oversight tools (document trackers, risk assessments, deliverables) to ensure efficient coordination and timely delivery
• Collaborate with Regulatory Affairs on submission strategy and responses to Health Authorities
• Manage a network of CMC-RA consultants and vendors, ensuring quality and alignment with project objectives
• Review and finalize externally drafted regulatory documents, maintaining full compliance and scientific clarity

More 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 pharmacist
• Solid knowledge of global CMC regulatory frameworks (EU, US, ICH), with experience across small 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 partners
• Analytical and systematic working style
• Fluent in English and French.

• 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.

Please contact our HR Department prior to submitting any profiles. We cannot accept unsolicited applications from agencies or recruiters.