Graham Higson has spent over 35 years in the pharmaceutical industry and, since January 2014 is Managing Director and owner of GCH Pharma Consulting Ltd, specialising in the provision of strategic regulatory advice, drug development, regulatory outsourcing and organizational development. He is currently a partner of, and responsible for Regulatory Affairs at, Avillion LLP, a drug development company with an innovative business model for the clinical development and approval of late stage pharmaceutical products. He is also a member of the NDA Regulatory Advisory Board, comprising former senior European regulators and industry experts.
Prior to establishing his own consulting company, he was Managing Director of NDA Advisory Services where he was accountable for the organization’s Regulatory and HTA Advisory Boards. Earlier in his career he was Global Head of Regulatory Affairs for the Medical Diagnostics division of GE Healthcare and previously he spent five years at AstraZeneca as Vice President and Global Head of Global Regulatory Affairs leading the regulatory organisations across six R&D sites in the UK, Sweden, US and Japan. This followed a number of senior regulatory positions both in the UK and USA during his 11 year tenure at Pfizer. Prior to that he worked at Gensia, Sandoz, Ciba-Geigy, Synthѐlabo and Baxter Healthcare.
He has also been a member of both the EFPIA and PhRMA regulatory affairs committees, the CMR Regulations Advisory Board and the TOPRA Regulatory Advisory Council.