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, 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 jidaen jit0417aen jpiy26aen