Senior Expert Regulatory Affairs - CMC/Biosimilars

Senior Expert Regulatory Affairs - CMC/Biosimilars

Shape CMC regulatory strategy for complex biologics in a fast-growing biotech environment

For a fast‑growing, internationally active biotech company focused on biosimilar development, we are currently looking for a Senior Expert Regulatory Affairs with a strong CMC focus. Workplace is Region Zug‑Zurich in Switzerland, 3‑day office required. This is a key role within a growing Regulatory Affairs team, contributing to multiple development programs and playing an active part in building high‑quality regulatory dossiers for biosimilar products.

Your Responsibilities

• Act as a senior regulatory expert with a focus on CMC
• Define and support CMC regulatory strategies
• Lead and review Module 3 documentation
• Contribute to regulatory submissions (EU, US, other markets)
• Prepare and support Health Authority interactions (EMA / FDA)
• Author and review b...