Meet the team
The people delivering real results
The Real Regulatory team consists of dedicated and experienced professionals with extensive
experience in the successful worldwide development of pharmaceutical products.
Paddy has over 30 years experience selling software and consultancy service in the Irish marketplace.
Throughout his career, Paddy has been involved with small companies that have achieved significant growth during his tenure.
In her over 20 years experience in the pharmaceutical industry, Karen has formed an expansive network of contacts in the pharmaceutical industry around Europe.
Karen is a member of the Regulatory and Clinical Steering Group for the Ethical Medicines Industry Group where she helps shape regulatory policy in the UK and EU.
Dorothée oversees and manages our EU office whilst providing expert consultancy input to her client projects.
Since 2003, Dorothée has gained extensive experience in the regulatory and compliance aspects of medicinal product development in Europe, including clinical trials, MAA and lifecycle management for small molecule & biotech products.
Leslie has worked in regulatory affairs since 1997, from human medicines to medical devices and veterinary medicines.
Leslie is a current holder of the Regulatory Affairs Certification [RAC(EU)] credential and a Fellow of The Organisation for Professionals in Regulatory Affairs (TOPRA). She received a TOPRA Distinguished Service Award in 2017.
Lucy joined Real Regulatory in September 2010 and has over 13 years experience in all aspects of regulatory affairs. Her main focus is in the clinical trials arena, project management and post marketing pharma regulatory affairs.
She is key to developing and maintaining relationships with new and existing client, managing all aspects of client's projects and providing management, support and training to other employees.
Lucy has demonstrated her ability to provide efficient, quality services that meet the needs of pharmaceutical clients.
Catherine holds a M.Sc. in Pharmaceutical Analysis from Trinity College Dublin.
Catherine has almost 20 years experience working in the pharmaceutical industry giving her experience in clinical trials, OTC products, generic products and innovator products. She has worked for several large generic and innovator pharmaceutical companies as well as a large multinational CRO. Catherine has worked in regulatory affairs in Europe, New Zealand, Australia and has experience making submissions in the Middle East, Japan and US.
Tanya has worked in the pharmaceutical industry since 2002, and has an extensive knowledge of pharmaceutical licensing legislation and regulatory documentation. She has worked both in regulatory affairs and medical writing, in a number of different types of organisation, including a national regulatory agency, pharmaceutical company, regulatory affairs consultancies and a medical writing consultancy.
Tanya holds a Master’s degree in Applied Biology from Birkbeck College, University of London, and a Bachelor of Science in Biology from the University of Sussex.
Niamh holds a B.Sc. in Analytical Science from Dublin City University and a BA in Pharmaceutical Business Operations from Griffith College and Innopharma Labs.
She has extensive experience in all aspects of QMS including auditing and regulatory affairs compliance, which she brought to Real Regulatory in 2016.
Rebecca holds an honours degree in Chemical Sciences with Medicinal Chemistry from Dublin Institute of Technology. Her passion for regulatory affairs began during her experience working for a Clinical Research Organisation.
Now with over 3 years Regulatory Affairs experience, Rebecca has provided regulatory support to global innovator pharmaceutical companies. She has been involved in work with specialised products such as Orphan Medicinal Products, Post-marketed medicinal product maintenance and investigational medicinal products. She is experienced in the field of clinical trial submissions, e.g. CTAs, substantial and non-substantial amendments within the European Market.
Fiona joined Real Regulatory in 2011, bringing with her 20 years’ experience in administration throughout various industries.
She maintains an excellent relationship with our consultants and works as our ISO document controller assisting in maintaining our quality standard.
She is integral to the day to day running of the Real Regulatory office.
Mary joined our office in 2012. With her she brought a wealth of administrative experience, great communication skills and a keen ability to multitask
She is responsible for keeping the office running, the calendar right and assisting all other staff members with their projects and deadlines.