Senior Expert Regulatory Affairs

vor 1 Tag

Zug, Zug, Schweiz gloor&lang AG Vollzeit
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

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