Senior Expert Regulatory Affairs - CMC/Biosimilars
On-site · Zürich, Zurich, Switzerland
Job Summary
Senior regulatory expert with a strong CMC focus to shape regulatory strategy for complex biologics and biosimilars. Lead/Review Module 3, contribute to EU/US/global submissions, prepare Health Authority interactions (EMA/FDA), author/regulatory documentation, and collaborate across CMC, Analytical Development, Clinical and external partners in a matrix, international setting. Requires MSc/PhD and 7+ years in Regulatory Affairs for biologics, with deep EMA/FDA knowledge, eCTD publishing, and experience across clinical and CMC regulatory documentation. Office-based role in the Zurich region with international exposure and high-growth biotech environment.
Required Qualifications
- MSc or PhD in biotechnology, biochemistry, biology or related field
- 7+ years of experience in Regulatory Affairs, focused on biologics / monoclonal antibodies (biosimilars preferred, not mandatory)
- Strong knowledge of EMA and FDA regulatory procedures
- Hands-on experience with eCTD publishing
- Experience with clinical and CMC-related regulatory documentation
- Excellent communication and organizational skills
- Collaborative mindset and ability to thrive in a dynamic, international environment
Desired Qualifications
- 7+ years of experience in Regulatory Affairs, focused on biologics / monoclonal antibodies (biosimilars preferred, not mandatory)
- Strong knowledge of EMA and FDA regulatory procedures
- Hands-on experience with eCTD publishing
- Experience with clinical and CMC-related regulatory documentation
- Excellent communication and organizational skills
- Collaborative mindset and ability to thrive in a dynamic, international environment
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.