Senior Expert Regulatory Affairs - CMC/Biosimilars
Description du poste
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, 3d 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 briefing books and regulatory documents
- Collaborate closely with CMC, Analytical Development, Clinical and external partners
- Work in a matrix organization across multiple projects
Your Profile
- 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
What’s on Offer
- Key role in a high‑growth biotech environment
- Exposure to complex, high‑impact biosimilar programs
- International, collaborative setup
- Competitive compensation and attractive benefits
