Karen Real Featured Image

Karen Real

SVP, Head of Regulatory Affairs

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 is an entrepreneur and senior pharma professional 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 March 2022 by tranScrip.  She headed up the regulatory function until May of 2023 and has now transitioned to a purely business development role.

 

Karen has a primary degree in chemistry 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 has 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.

The remit of her role at tranScrip is to sell the collective breadth of expertise within the tranScrip team for contracts ranging from multifunctional team support of projects through to provision of specialist skills on an FTE basis. 

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