About the Company
We are working with a European biotech organisation, who are dedicated to improving the lives of patients with rare diseases. They have achieved multiple global filing success from the FDA, EMA and PMDA, and are now launching into further markets around the world. The portfolio ranges from phase 2 development to approved products, with multiple new indications currently being explored across different therapeutic areas.
  
About the Role
This role is an exciting opportunity to join as a Global Regulatory Lead. Reporting into the Global Head of Regulatory Strategy, you will be responsible for global filing strategy of a rare immunology program. You will provide global regulatory leadership of the program, developing a global strategy including risk assessment & mitigation strategy. You will lead major regulatory agency meetings (with FDA, EMA/ CHPM, PMDA), and will present to senior leadership teams regarding your assigned program. This role may also be responsible for oversight or management of other Regulatory Affairs team members supporting your program.
  
We are looking for candidates who have the below experience:

• Experience of leading a global regulatory filing strategy for a program (from phase 3 to approval to post-marketing & geo-expansion)
• BLA experience is a must, additional experience with MAAs in Europe & Japan will be very advantageous
• Strong knowledge in drug development & the rare disease regulatory landscape
• Immunology experience will be beneficial but not essential
• A willingness to work operationally and “hands-on” when required to get tasks completed
• A desire to work in a biotech environment which can be fast-paced & demanding, whilst also being able to adapt to any strategic changes in pipeline direction.

  
Please apply with an up to date CV for consideration.