Global Regulatory CMC Leadership Role

1 week ago


Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time
CMC Regulatory Strategy Lead

About Our Company

Novo Nordisk A/S is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily.

About the Job

We are seeking a highly skilled and experienced Regulatory Affairs Director for CMC Biologics & Rare Diseases. As the successful candidate, you will be responsible for developing and executing regulatory CMC strategies and global approvals for the Biologics & Rare Diseases product portfolio.

Your Key Responsibilities

  • Develop and execute regulatory CMC strategies and global approvals for the Biologics & Rare Diseases product portfolio.
  • Lead and develop leaders and specialists organized in three departments with more than 30 colleagues in Søborg, with a wide range of expertise and experience.
  • Collaborate with key stakeholders to deliver regulatory approvals and drive excellence in our pipeline.

About You

To be successful in this role, you will need to have:

  • A Master of Science degree in natural sciences such as engineering, pharmacy, chemistry or similar.
  • 10+ years of experience as a leader and minimum 5 years as second line leadership is required.
  • 10+ years of experience from the pharmaceutical industry within Regulatory Affairs.
  • Experience from working in a global function with manufacturing or CMC, QA or a function collaborating closely with regulatory CMC is an advantage.


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