Head of Regulatory Affairs, EMEA
Location: Remote in Europe (with travel to HQ required)
  
About the job
We are working with a European biotech organisation, who are developing novel therapeutics for a range of rare diseases. They have achieved FDA success with a few of their programs, which have now been launched in markets around the world. The portfolio now ranges from preclinical to approved products, with multiple new indications currently being explored.
This role is an exciting opportunity to join as Head of Regulatory Affairs EMEA. Reporting directly to the Global Head of Regulatory, and a dotted line to the European General Manager, you will play a pivotal role in ensuring regulatory approval across a diverse pipeline. This role is very visible within the organisation and will sit on the European leadership team to make strategic decisions for the direction of the portfolio. You will lead a team of 6 Regulatory professionals, provide them with direction & motivation and give them a voice at the table.
We are looking for candidates who have the below experience:

• Experience of marketing applications to EMA is required, and additional experience of MAAs across EMEA markets will be beneficial
• Team leadership experience is a must- having managed multiple regulatory professionals in a previous role
• Commercial strategy experience, with the ability to work closely with senior stakeholders such as European GM
• Product portfolio experience, with previous oversight of multiple products at different stages of their development lifecycle (both clinical & commercial experience is ideal)
• A clear passion & motivation for bringing rare disease treatments to patients with unmet medical need

Please apply with an up to date CV for consideration.