Robert Blakie is Regulatory Affairs Director at mAbxience. He brings to the company 40 years’ experience working in different regulatory affairs environments. His geographical experience has covered primarily Europe interacting with both EU National Regulatory Agencies and the EMA, and the Rest of the World; he has also covered US regulatory affairs and interacted with the FDA as well as with the PMDA in Japan.
Since starting his professional career, Robert has covered most therapeutic areas but principally oncology, cardiovascular and gastro-intestinal, and both small molecules and biopharmaceuticals, including biosimilars.
In G D Searle, where he worked for 6 years, Robert established a competent and successful regulatory affairs unit as Regulatory Affairs Manager. Later on he joined Astra AB as Director of Regulatory Liason, Corporate Regulatory Affairs, based in Sweden, being responsible for the co-ordination of regulatory activities within the Astra group of companies on a worldwide basis, being a key player in the decision to submit Astra’s first ever Mutual Recognition application.
After a wide-ranging career, with experiences as Head of International Regulatory Affairs (British Biotech Pharmaceuticals), Vice President of Scientific Affairs (Faulding Pharmaceuticals, now Hospira), Director & General Manager of a consultancy company (ERA Consulting UK) and Head of European Regulatory Affairs (Daiichi Sankyo Development), Robert joined mAbxience to be responsible for all regulatory affairs activities for the portfolio of the company’s projects on a global basis.
Robert holds a BSc in Biological Sciences and an HNC in Business Studies.