Karen is a senior pharma professional and entrepreneur who has worked in the pharmaceutical industry for over 30 years. In 2002 she co-founded Real Regulatory Ltd, a regulatory consultancy, which was acquired in 2022 by tranScrip, and now heads up tranScrip’s regulatory team.
Karen graduated with a primary chemist degree from NUI Galway in Ireland.
She spent initial years in a structural chemistry role in big pharma. She then moved to regulatory compliance and CMC in the generics industry. Subsequently, she worked in a variety of roles in biotechs and CROs, building an extensive experience in all aspects of the life of a medicine, from development strategy, sponsor oversight of clinical trials, and gaining approvals and lifecycle management for MAAs in Europe.
Karen is responsible for team management, business development and the service realisation process of tranScrip’s regulatory affairs team.
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