Carolyn brings wide ranging experience across Global Regulatory Affairs and Pharmaceutical Development, covering multiple Therapy Areas (Infection, Oncology, CV, Diabetes). Carolyn graduated from Edinburgh University with a PhD in peptide chemistry. She started her career with AstraZeneca in the Pharmaceutical Development department, working on early product development. After joining Regulatory CMC, Carolyn was involved with the creation of one of the first AZ marketing applications authored using ‘Quality by Design’ (QbD) principles.
Carolyn’s current focus is on the CMC content of global marketing applications, including strategies to manage post approval change for a complex, multi-market, drug-device combination product. As a result of this, she has led technical discussions with international Regulatory agencies such as ANVISA (Brazil) and CDE (China). Her current interests cover small and medium sized molecules, polymers, sterile processing and combination products.
CMC dossier content strategy and device Post-approval change management