Karen Quigley has over 25 years experience in formulation development, CMC regulatory affairs and clinical regulatory affairs in pharmaceutical companies in the UK, USA, and Ireland. Proven track record of supporting regulatory applications e.g. Clinical Trial Applications, Marketing Authorisation Applications, and Scientific Advice. Karen is experienced in leading development teams in developing Regulatory strategies that are appropriate and take advantage of global regulatory systems and processes, in particular, the application of innovative regulatory pathways, to expedite development. In recent years, Karen worked as a Regulatory Affairs Consultant with clients including Alkermes, Transition Therapeutics, and Elan Pharmaceuticals. Karen has previously held senior Regulatory Affairs leadership and technical positions at Pfizer, Aventis, and GSK. Karen has also worked in the Dublin Institute of Technology teaching at undergraduate and postgraduate level in Pharmaceutical Sciences covering Pharmaceutical and Biopharmaceutical Regulation, Drug Development, Clinical Trial Applications, GMP, Quality, Manufacturing and Control and Validation.
Karen earned her MSc. and BSc. in Chemistry from University College Dublin, Ireland and her MBA from St. Joseph’s University, Philadelphia, USA. She is a member of Drug Information Association (DIA), RAPS and TOPRA.
Since joining Cilatus, Karen has lead multiple CMC Regulatory Affairs projects, reviewed and authored INDs and IMPDs, and acted as the CMC Regulatory Affairs leader for clients. Karen has recently acted as EU Regulatory lead responsible for approved products within Europe of a client. This includes defining and executing strategies for product launches, post-marketing regulatory submissions and required maintenance and the development of an artwork management system.