A leading rare disease biopharmaceutical company are looking for an experienced Regulatory Affairs Manager to join their team in the UK. The company uses innovative biotherapies in the treatment of serious and rare conditions. They are a patient-centric organization, committed to providing therapies to improve the quality of life for people across the globe.
You will be working as part of a close-knit team in the UK, responding to the growing pipeline of the company and preparing and maintaining national labelling and dossiers. This role brings with it the unique opportunity to work for a global company with an exciting pipeline whilst working for an affiliate as part of a very small but focused team in the UK.
- Preparation and maintenance of national labelling
- Preparing documentation and data for national submission
- Maintain global regulations and review global SOPs, assessing their impact on local processes
- Liaise and negotiate with Health Authorities and GRA
- Biologics Regulatory experience
- Experience of Brexit planning
- Experience with UK and EU Regulatory Affairs
- Experience of working cross-functionally
- Experience of liaising with HAs
If you are interested in this role, please send an updated CV to Laura Hulley at email@example.com.