Senior Expert Regulatory Affairs CMCBiosimilars

Zug - Switzerland

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

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

Whats 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

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