Senior Director Regulatory Affairs- Rare Disease

Senior Director Regulatory Affairs, Global Therapeutic Area Head Location: Candidate must have Right to Work in the UK Remote Working with International travel to HQ required About the company: 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. About the role This role is an exciting opportunity to join as Senior Director Regulatory Affairs, Therapeutic Area Head. Reporting directly to the Global Head of Regulatory, you will play a pivotal role in ensuring regulatory approval across a diverse pipeline of assets. This role is very visible within the organisation and will make strategic decisions for the direction of the portfolio. You will lead a small team of 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 FDA and EMA is required Rare disease & orphan drug experience is required for this role Experience in haematology, rheumatology or dermatology will be very 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 (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.