Kathleen O’Neill is a pharmacist with more than 25 years of experience in the Pharmaceutical Industry. After completing her M. Sc. in Pharmacy she worked in product development in Ireland and the US. Later she has worked in Regulatory Affairs in Ireland, France and Australia and gained experience of EU, US, and global regulatory systems while working with BMS, Mayne Pharma, GSK, and Astra Zeneca. From 1996 to 2007 she worked as a Senior Pharmaceutical Assessor with the HPRA reviewing both MA and CT applications for small molecules, biopharmaceuticals, and vaccines.
Kathleen has worked on all dosage forms including oral dosage forms, parenterals and topicals for human and veterinary products. She represented the HPRA at the Biotech Working Party and has acted as Rapporteur for Centralized and MR procedures. Since leaving the HPRA she has worked as a consultant in CMC Regulatory and Regulatory Affairs for various clients including Elan Pharmaceuticals, Astellas, and Genzyme. She has extensive experience in developing and authoring IND, IMPD, MAA, NDA, BLA filings and lifecycle management. Her roles have included regulatory filings, training and mentoring, regulatory strategy development, RA quality systems, technical advice and report writing. Her key strength is providing expertise in CMC Regulatory filings at all stages of development including Scientific Advice applications. She has a strong technical background. She is enthusiastic and focused with good problem-solving skills.
Kathleen holds a first-class honours degree in pharmacy and M. Sc. from Trinity College Dublin. She also holds a postgraduate qualification in Biopharmaceutical Science. She is a member of the Pharmaceutical Society of Ireland and TOPRA.
At Cilatus, Kathleen has lead multiple CMC Regulatory Affairs projects, reviewed and authored INDs and IMPDs, and acted as the CMC Regulatory Affairs leader for clients. She has been instrumental in the development of Cilatus’ process validation and characterization approach that has been implemented at various clients.