Fiona oversees the regulatory team and ensures that medicinal and biotechnological projects meet their objectives and are delivered efficiently and on budget.
Value to clients
By applying her broad experience to projects, Fiona delivers strategic insight to early and late phase development projects. She also has hands on experience of product registration and lifecycle management that assures a robust but pragmatic approach evaluation.
- An in depth knowledge of biopharmaceutical product development
- Great experience in managing scientific advice meetings with EU agencies
- Proven track record of project leadership, including co-ordination of remote teams and problem solving
- Well versed in EU and International market clinical trial applications and lifecycle maintenance.
Fiona has worked as a regulatory consultant for a number of years. After graduating with an honours degree in microbiology, Fiona worked in Regulatory Affairs at Aventis, before progressing to management roles in Microscience. Latterly she held positions at Associate Director and Director level at Biogen Idec, with varying responsibilities including rest of world markets, advertising, labelling and promotion. Her time at Biogen culminated with her reaching Director of Development.
Other things about Fiona
- Committed to regulatory team training and talent development
- Started her career as a scientist at the National Institute for Biological Standards and Control
- Successfully obtained two approvals from DEFRA for deliberate release of genetically modified organisms in a previous role.