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acadiapharmaceuticals

Sep 03

Associate Director Regulatory Affairs Europe

Onsite Zug, Switzerland

regulatory affairs

greenhouse

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Job description

You will oversee regulatory strategies for product development in Europe. This role involves managing submissions and ensuring compliance with regulatory standards.

Details

  • Zug, Switzerland, work from office
  • 7+ years of relevant drug development experience, including 5 years in regulatory affairs in the EU

The work

  • Manage regulatory activities for product development and commercialization
  • Plan and coordinate Pediatric Investigation Plans and Orphan Designations
  • Lead the European Regulatory Subteam during major submissions
  • Monitor and interpret regulatory requirements to ensure compliance