Amy Smith has over 20 years of experience in the pharmaceutical industry mainly focused in Regulatory Affairs CMC for biologics, vaccines & small molecules. Prior to joining the leadership team at Cilatus, Amy held the leadership positions of Director, Regulatory Affairs CMC for the EMEA region at NPS Pharma (now part of Shire) and Director of Regulatory Affairs CMC at Elan where she led global CMC regulatory affairs for all of Elan Pharmaceutical products. In addition, Amy previously held Regulatory and Regulatory CMC positions at Janssen Alzheimer’s Immunotherapy (a J&J company) at Wyeth BioPharma, Real Regulatory and GMG Biobusiness
Amy has successfully lead the preparation and delivery of regulatory strategies for global drug development and life cycle management for biologics and small molecule products in therapeutic areas such as oncology, neurology, and various orphan diseases. She has broad experience in technical and regulatory aspects of the manufacture and control of biologics, from pre-clinical to post-approval stage with global regulatory experience, for procedures including CTA/IND, MAA/BLA, and post-approval submissions, EU and US Scientific Advice, Orphan Drug applications and drug safety reporting. Amy has experience in managing and leading agency interactions including EMA, EU national and FDA Scientific Advice. She has also developed and implemented Regulatory change control and MA compliance programs.
Amy holds a first-class honours degree in Biotechnology from Dublin City University. She is a member of TOPRA and RAPS.
As part of the leadership at Cilatus, Amy has led multiple CMC Development and CMC Regulatory projects. She is instrumental in the Regulatory aspects of each client assignment project and developed successful Regulatory strategies, execution plans, and realistic timelines for our clients.