Ms. Mary Rafter

Specialties: Regulatory

Ms. Mary Rafter

Mary Rafter is a pharmaceutical professional with experience across regulatory affairs, regulation of medicines, quality and scientific support. She is currently a consultant contributing to academic education programs.

Following a period in pharmaceutical quality control for Rice Steele & Co., Ms. Rafter joined the National Drugs Advisory Board (forerunner of the Irish Medicines Board) in 1983. There, she spent fourteen years as a pharmaceutical assessor. In this role, she was involved in clinical trials and the quality assessment of EU and national applications. In that time, she also developed a specialization in inhaler technologies.

In other roles, Ms. Rafter served as Technical and Marketing Services Manager for Cahill May Roberts, EU-Qualified Person in batch release with Wyeth and as Senior Regulatory Affairs Manager for Pfizer (formerly Wyeth Medica Ireland). There, her responsibilities included scientific support, training and coordination of several major regulatory projects.

She received her Bachelor of Science Degree in Pharmacy from University College Dublin and her Master's of Science Degree in Pharmaceutical Medicine from Trinity College. She also maintains her status as a registered pharmacist with the Pharmaceutical Society of Ireland.

Ms. Rafter has represented the Irish Medicines Board at CPMP/CHMP/EMEA as a pharmaceutical expert. She was also a delegate to the EU Working Party on Strategy for CFC Inhaler Phase-out and member of the EU Working Group on the Implementing Guidelines for Clinical Trials Directive.