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.