Lucy Herlihy

Lucy is a Director, Regulatory Affairs at tranScrip where she leads a team of experienced regulatory affairs professionals.  She has worked in regulatory affairs for 19 years across various consultancies.  Her main area of expertise are the regulatory aspects of European clinical trials; where she oversees European and UK Clinical Trial Application submissions and advises on clinical trial strategy and intelligence.   

In addition, Lucy co-leads the regulatory intelligence initiative across tranScrip, ensuring that all team members are kept fully up to date with regulatory developments and requirements. 

Lucy began her career in research at Queen’s University Belfast, later working in assay development at Medeva Group. She then advanced into clinical data management at Quintiles, where she became Senior Clinical Data Co-ordinator and Lead Data Manager, managing multiple global clinical trials. 

Her regulatory affairs career developed through her position at European Medicines Registration Consultancy (EMRC), where she managed submissions across EU territories including Clinical Trial Applications, amendments, MAA submissions, and post authorisation lifecycle activities.  Lucy then joined Real Regulatory as a senior regulatory affairs consultant in 2010 and eventually tranScrip upon the acquisition of Real Regulatory in 2022.  

At tranScrip Lucy is responsible for the development and execution of regulatory strategies in support of clients’ corporate objectives.  Her focus currently is in providing clinical trial expertise, regulatory intelligence, strategic advice and due diligence to a wide variety of clients and she has managed many clinical trial regulatory procedures and has a particular interest in oncology clinical trials. Her involvement extends from Phase 1 trials for first-in-human studies to large global phase 4 studies.  She has worked with multiple dosage forms; small molecules, biologicals and ATMPs.    

Lucy’s expertise also includes MAA submissions, and post authorisation lifecycle management activities. She has represented clients at scientific advice meetings with Competent Authorities. She has a demonstrated ability to manage and complete tasks and to provide efficient, quality services that meet the needs of pharmaceutical clients.   

Her current role involves specialising in clinical trials while also developing expertise in all areas of regulatory affairs, developing and maintaining relationships with new and existing clients, managing all aspects of client’s projects, managing and providing support and training to other employee’s.  

Lucy graduated from University College Cork with an honour’s degree in Microbiology.  She is a registered member of TOPRA.