Mary Rafter

Mary Rafter

Regulation Affairs Consultant

Mary brings over thirty years’ experience, working across several areas of the pharmaceutical sciences, including industry, governmental and academic roles, to HiTech Health.

Mary has over 18 years expertise as a regulator, having worked in the quality assessment of EU and National applications for the Irish Regulator, the Health Products Regulatory Authority. Mary has represented the Irish regulator at various European Medicines Agency committees, including CHMP and the EU Working Group on Implementing Guidelines for the first EU Clinical Trials Directive

Mary’s career has been interspersed with periods spent in the industry, including roles as Technical Services Manager for the pharmaceutical wholesaler Cahill May Roberts , as an EU Qualified Person with Wyeth and as Senior Regulatory Affairs Manager for a global team based at Pfizer in Ireland. Recent consultancy assignments included a Global RA CMC Lead role for Genzyme (a Sanofi company). She currently works as a course director and tutor in the field of pharmaceutical training, and also contributes to academic education programmes.

She holds a Bachelor of Science Degree in Pharmacy from University College Dublin. She obtained a Masters’ of Science Degree in Pharmaceutical Medicine from Trinity College Dublin in 2010 and is a registered Pharmacist.