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Regulatory Affairs Specialist

3 weeks ago


Taastrup, Høje-Taastrup Kommune, Denmark Novo Nordisk AS Full time

About the Role

We're looking for a highly skilled CMC QA Integration Specialist to join our team and drive the quality integration of acquired corporate assets. This role requires a strong understanding of CMC, QA, and production-related processes, as well as excellent communication and problem-solving skills.

Key Responsibilities

  1. Integration Strategy
  • Provide CMC QA advice and directions to the integration strategies and transition activities during due diligence and merger & acquisitions
  • Set new standards and processes for quality integration of corporate assets into the Novo Nordisk pipeline

Requirements

  • Masters degree or Ph.D. in Pharmacy, Chemistry, Biology, Engineering, or similar
  • Extensive experience in CMC, QA, or production-related roles
  • Gained experience within the pharmaceutical industry
  • In-depth knowledge of the pharmaceutical product value stream and expertise in GxP regulations and guidelines (EU and US)
  • Fluency in English, both written and spoken

Our Company Culture

We strive for a culture that celebrates diversity, inclusivity, and collaboration. Our team members are passionate about making a difference in patient care and are driven by a shared commitment to excellence.