Senior Regulatory Affairs Clinical Specialist

Zealand Pharma AS

Copenhagen, Denmark
**
Global regulatory submissions experience
Eu maa and us nda documentation
Health authority interaction strategies
** Zealand Pharma AS is seeking a Senior Regulatory Affairs Clinical Specialist to provide regulatory guidance across clinical development programs, particularly focusing on global submissions and health authority interactions. The ideal candidate will have a strong regulatory background, excellent communication skills, and a collaborative mindset, contributing to the company's mission of developing innovative peptide-based medicines. **

Job Summary

  • This role provides regulatory input and direction across clinical development programs to enable timely, high-quality submissions.
  • The successful candidate will act as a regulatory lead in clinical trial teams, supporting planning, execution, and reporting phases.
  • Zealand Pharma offers a unique culture characterized by excellent teamwork, strong engagement, and a focus on patient impact.

Matching Summary

Match Score: 75

** Zealand Pharma AS is seeking a Senior Regulatory Affairs Clinical Specialist to provide regulatory guidance across clinical development programs, particularly focusing on global submissions and health authority interactions. The ideal candidate will have a strong regulatory background, excellent communication skills, and a collaborative mindset, contributing to the company's mission of developing innovative peptide-based medicines. **

Skills & Requirements

Must-have

  • Global regulatory submissions experience
  • EU MAA and US NDA documentation
  • Health authority interaction strategies
  • Veeva Vault software proficiency
  • Clinical trial application expertise

Nice-to-have

  • Strong collaborative mindset
  • Process improvement initiatives
  • Strategic thinking capabilities
  • Innovative peptide medicine focus

Key Requirements

  • Master's degree in Life Science or Health Science
  • Several years of pharmaceutical regulatory experience
  • Proven experience with clinical trial applications

Work Rights

Not specified

Tailored Resume

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