Diamond BioPharm Limited is part of a group, including Diamond PV Services Limited and Diamond Compliance Limited, specialising in Regulatory Affairs activities including eCTD submissions. The group offers an all round service to companies of any size, covering all regulatory, pharmacovigilance, leaflet testing and compliance needs. We specialise in Europe and United Kingdom, and USA. Specialist area of interest - advanced therapies, in particular gene and cell therapies. Biosimilars are also an intriguing area.We have been established since 2005, and our mission is to provide support at the highest level of quality possible. Please visit our website to view all of our support capabilities.

My role at Amgen was primarily leading the EU Regulatory team, building it both in numbers and strength and projects evolved. Being lucky enough in this role to still remain hands-on in development and regulatory activities for the worlds number 1 biotechnology company, this was my most exciting and fulfilling position in the whole of my career. I was part of the management teams both in Cambridge and Europe, and interacted heavily with global RA in Thousand Oaks. I had a short spell of responsibility for pharmacovigilance.

In this position I lead, built up and developed the Regulatory Affairs team for MSD in UK. In addition to all UK and Irish Regulatory activities, we become heavily involved in helping to lead the way for European submissions. I also had an oversight responsibility for pharmacovigilance during my years at MSD.

My very first position into Regulatory Affairs, where I learnt the basics and my knowledge grew over the 3 years, from clinical trials work, marketing applications and support. At that time my speciality was CMC, being a Pharmacist, later to diverge across the whole range of disciplines - nonclinical and clinical.