Senior Expert Regulatory Affairs - CMC/Biosimilars

About the job

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