Regulatory Affairs Expert

4 days ago


Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom CT19 Full time

Estimated salary: £120,000 - £180,000 per annum.

We are seeking a highly skilled Senior Director Regulatory Affairs to join our team at CT19. As Global Therapeutic Area Head, you will play a pivotal role in ensuring regulatory approval across a diverse pipeline of assets.

This is an exciting opportunity for a senior professional with experience in marketing applications to FDA and EMA, rare disease and orphan drug experience, and people management skills. You will lead a small team of Regulatory professionals, providing direction, motivation, and strategic decision-making support.

About the Company:

CT19 is a European biotech organisation developing novel therapeutics for a range of rare diseases. We have achieved FDA success with several programs, which have been launched in markets around the world. Our portfolio ranges from preclinical to approved products, with multiple new indications currently being explored.

About the Role:

In this role, you will be responsible for ensuring regulatory compliance and strategy development for our pipeline of assets. Your experience in haematology, rheumatology, or dermatology will be beneficial, as well as your ability to work closely with senior stakeholders such as Commercial & General Managers.

  • Commercial strategy experience
  • Product portfolio experience
  • Rare disease treatment passion


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