Director of Regulatory Compliance

14 hours ago


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

**CT19 Overview**

We are a dynamic biotech organisation passionate about developing innovative therapies for rare diseases.

We have achieved significant milestones in our journey, including FDA approvals and product launches in global markets.

**Job Description:**

This is an exciting opportunity to join us as Senior Director Regulatory Affairs, Therapeutic Area Head. You will lead a small team of Regulatory professionals and play a pivotal role in ensuring regulatory approval across a diverse pipeline of assets.

**Responsibilities:**

  • Experience of marketing applications to FDA and EMA is required.
  • Rare disease & orphan drug experience is essential for this role.
  • Haematology, rheumatology or dermatology experience will be beneficial.
  • People management experience is a must, ideally having managed a team of direct reports.
  • Commercial strategy experience, with the ability to work closely with senior stakeholders such as Commercial & General Managers.
  • Product portfolio experience, with previous oversight of multiple products at different stages of their development lifecycle.

**Salary and Benefits:**

We offer a competitive salary, excellent benefits package, and opportunities for professional growth and development.



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