Roy is a Pharmacist by training graduating from Nottingham University, UK and now based in Sweden. During his early formative career, he gained experience in pharmaceutical development and manufacturing.
He is an experienced Pharma Industry & Regulatory CMC professional having spent time as a quality assessor at MHRA and with over 25 years in large pharma organisations leading numerous small molecule projects from FTiH through Marketing Authorisation and launch.
As an Independent Consultant he has worked with many small companies as well as collaborating with consultancy firms & a UK based pharmaceutical development service company. He is currently supporting the South African Agency (SAHPRA) as a Quality/CMC reviewer supporting their generic backlog programme and has recently started supporting a Swedish based rare disease Biotech company with their biologics portfolio.
Roy has successfully led 4 major global submissions through Phase 3 to marketing authorisation approval. His key area of regulatory scientific expertise and interest centres on biopharmaceutics aspects of solid oral dosage forms of small molecules and the bridge between quality performance and the pharmacokinetic profile linked to safety and efficacy.