Joanna has over 30 years of experience in regulatory affairs for pharmaceutical companies while working in the UK regulatory agencies. She has worked on hundreds of applications for drug approvals in the global regulatory markets. Joanna’s experience covers drug development, from first in man to phase 4, submitting INDs, gaining approval CTAs and obtaining scientific advice from Regulators for small molecules and biotechnology. Joanna has held senior positions as the Global Regulatory Lead for various therapeutic areas including vaccines, oncology and HIV products, she has extensive experience with US and EU paediatric submissions and Orphan Designations. She has previously had both permanent and interim roles as Head of Regulatory for start-up and established companies. While working for the Medicines and Healthcare Products Regulatory Agency (MHRA), Joanna was senior assessor responsible for Biotechnology applications considered by the Committee on Human Medicinal Products (CHMP). Joanna has held board level positions and has been involved with fund raising for start-up companies, as well as writing business plans. Joanna is a member of the Royal Pharmaceutical Society of Great Britain, a Fellow of The Organisation for Professionals in Regulatory Affairs (FTOPRA), a Fellow of the Royal Society for the encouragement of Arts, Manufactures and Commerce (FRSA) and Fellow of the Royal Society of Medicine (FRSM). Joanna has a BSc Pharmacy (Hons) and a first class degree in Law.
product development , biotechnology , Business management