Description

***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.*