Paddy has over 30 years experience selling software and consultancy services in the Irish marketplace.
As Sales Director for Kerridge Computer Company, he established and maintained the Kerridge Sales Office in Singapore for the ASEAN region.
As Managing Director of Bromley Group, Paddy was the main driving force behind growing the business from a small Business Intelligence Software supplier to one of the leading providers of Data Warehousing and Business Intelligences Solutions in the Irish marketplace, servicing clients such as AIB Bank, Bank of Ireland, EMC Corporation and Enterprise Ireland.
Throughout his career, Paddy has been involved with small companies that have achieved significant growth during his tenure.
Karen has over 20 years industrial experience in the pharmaceutical industry.
She has progressed from a technical position with the (then) Glaxo Group Research in the UK to hold Regulatory positions with the Merck Generics Group in both the UK and Ireland, with Dermal Laboratories in the UK and, prior to establishing Real Regulatory, with a Contract Research Organisation based in Dublin, Ireland.
Karen has an excellent track record in development strategy, driving and managing virtual teams, regulatory aspects of supply chain rationalisation, regulatory aspects of clinical trials, managing GCP compliance, gaining approvals for marketing authorisation applications and lifecycle management of approved products in Europe.
She has an extensive network of contacts in the pharmaceutical industry around Europe. Karen is currently also a member of the Regulatory and Clinical Steering Group for the Ethical Medicines Industry Group.
This provides her with an opportunity to contribute to industry and competent authority discussions, helping to shape regulatory policy in the UK and EU.
Managing Consultant (Ire)
Dorothée’s expertise are in the area of post marketing activities and clinical trials development in Europe. She has direct experience with authorities in Ireland, the UK, France and Belgium. Dorothée also has experience in the CMC arena, and in project management.
Dorothée manages Real Regulatory’s in-company and consulting services to provide clients with the advice and guidance they need for a flawless approach to meeting regulatory requirements. Dorothée has expertise and experience in both the domestic and wider European market places.
Dorothée joined Real Regulatory in 2006. Prior to this she worked at the Wyeth Pharmaceuticals manufacturing plant in Newbridge, Ireland. At Wyeth, Dorothée played a key part in the European Product Compliance (EPC) project in 2004/2005.
Dorothée began her education studying Biological Science in France before relocating to Ireland where she graduated with a National Diploma in Analytical Science at IT Carlow in 2003. Further study earned her a Bachelors Degree in Pharmaceutical Technology at IT Tallaght in 2005.
In her free time, Dorothée has a growing interest in mountain biking and hand craft projects such as soap and candle making.
Managing Consultant (UK)
Leslie has worked in regulatory affairs since 1997, mainly in human medicines, but also encompassing medical devices and veterinary medicines. She is experienced in managing multiple regulatory projects simultaneously, working in matrix organisations, both within small/medium pharma and as consultant/CRO with small/medium/large pharma clients. She has CTA experience in Phase 1-4 studies, including first-in-human and paediatric studies, mostly in EU but also in eastern Europe, Israel and India; therapeutic area experience includes oncology, endocrinology, neurology, respiratory, rheumatology and HIV. Leslie’s MAA experience includes new MA applications as well as post-registration maintenance and variations, mostly in the EU but also in the Americas, Middle East, Africa, and Asia Pacific. MAA therapeutic area experience includes oncology, gene therapy, endocrinology, antibiotics, multiple sclerosis, haematology, dry eye syndrome, hypotension and veterinary anaesthesia. Leslie has a particular interest in early phase clinical regulatory development, and has prepared orphan drug designation and PRIME applications, and scientific advice/protocol assistance packages.
Leslie is a current holder of the Regulatory Affairs Certification [RAC(EU)] credential, with triennial recertification maintained. She is a Fellow of The Organisation for Professionals in Regulatory Affairs (TOPRA) and currently active as the Editor-in-Chief of the TOPRA journal Regulatory Rapporteur. She is a member of the Regulatory Affairs Professionals Society (RAPS) and was a member and the Chair of the RAC(EU) Examination Committee. She was a Shortlisted Nominee for the TOPRA Communication Award in 2016 and received a TOPRA Distinguished Service Award in 2017.
Regulatory Affairs Manager
Lucy has over 6 years regulatory affairs experience specialising in pharmaceutical regulatory affairs. Her main focus is in the CMC arena, project management and post marketing pharmaceutical regulatory affairs.
Lucy joined Real Regulatory in September 2010, having previously worked for a number of years in another regulatory affairs consultancy. Prior to that she worked as a senior clinical trials manager with over 7 years experience of data management and clinical trials processes and systems within a Clinical Research Organisation.
Lucy also has experience in effectively managing multiple tasks and clients simultaneously both in her previous role as a lead data manager for the corporate project team and in a regulatory affairs role. 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 developing expertise in all areas of regulatory affairs, developing and maintaining relationships with new and existing clients, managing all aspects of client’s projects, providing support and training to other employee’s.
Lucy graduated from University College Cork with a degree in Microbiology. Lucy’s interests include competitive badminton and walking in the countryside.
Senior Regulatory Affairs Consultant
Catherine has over 15 years’ experience working in the pharmaceutical industry, specifically in Regulatory Affairs. During this time she has worked for several large generic and innovator pharmaceutical companies. In addition, Catherine has experience working in a large multinational CRO.
During her career, Catherine has worked in the areas of clinical trials, OTC products, generic products, innovator products and has broad experience in post-marketing procedures, manufacture, supply chain and life-cycle management of products approved both in Europe and world-wide.
Catherine has spent over 9 years working in both Australia and New Zealand giving her a good knowledge of world-wide regulatory requirement and procedures. Catherine holds a M.Sc. in Pharmaceutical Analysis from Trinity College Dublin.
Catherine likes to relax by paddle boarding, cycling, cooking and loves to travel when not busy working.
Senior Regulatory Affairs Consultant
Lorraine has over 15 years’ experience working in the pharmaceutical industry, specifically in Regulatory Affairs. During this time, she has worked for several large pharmaceutical companies and Clinical Trial Development Organisations.
Lorraine has considerable strategic and operational experience in EU post authorisation activities and in late-stage global clinical development activities including management of CRO activities.
Lorraine spent 3 years working in Australia giving her a good knowledge of world-wide regulatory requirements. Lorraine holds a BSc. Industrial and Environmental Science from Carlow Institute of Technology.
Senior Regulatory Affairs Consultant
Tanya has more than 14 years of experience in the pharmaceutical industry, both in regulatory affairs and medical writing.
Tanya has worked in a number of different types of organisation, including a national regulatory agency, pharmaceutical company, regulatory affairs consultancies and a medical writing consultancy. These roles have provided her with a wide-ranging experience of regulatory affairs, and an extensive knowledge of pharmaceuticals, pharmaceutical licensing legislation and regulatory documentation.
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.
Regulatory Affairs Consultant
Since joining Real Regulatory in 2016 as a Regulatory Consultant, Niamh has been gaining clinical trial experience in addition to her QMS work.
While undertaking a BA in Pharmaceutical Business Operations, Niamh was particularly interested in regulatory affairs and clinical trials and decided to move into this area. 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.
Niamh has over 20 years’ experience in international medical device and pharmaceutical manufacturing Quality Management Systems. Niamh started her career as a Pharmaceutical Analyst in R&D before taking up a position as a QC Chemist with an international bulk pharmaceutical manufacturer.
Niamh then moved to the medical device sector working for a leading medical device company where she held the position of QC Manager for 12 years gaining extensive experience in all aspects of Quality Management including auditing and regulatory affairs compliance.
Regulatory Affairs Associate
Rebecca is highly motivated with an unmistakable drive to succeed in her career in the pharmaceutical industry. She 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 as an intern for a Clinical Research Orgnisation in Dublin and she strives to further her knowledge and develope a deeper under standing of the industry.
Rebecca joined the Real Regulatory team in 2016 as a Regulatory Affairs Associate. Her current role involves assisting senior consultants and managers with on-going projects while keeping up to date with new or changing regulatory requirements in relevant territories.
In her free time Rebecca enjoys socialising with friends and keeping active through ballet, Pilates and the gym.
Fiona is independent, confident, determined and loyal individual who effectively multitasks. She joined Real Regulatory in 2011.
With 20 years’ experience in administration throughout various industries, Fiona’s role at Real is integral to the day to day running of the office, from administration to social functions.
Fiona maintains an excellent relationship with our consultants and works as our ISO document controller assisting in maintaining our quality standard.
When not at work Fiona is kept busy looking after her young daughter and enjoys spending quality family time together. She also enjoys socialising with friends, going to the cinema and baking.
An organised, experienced office administrator, with good communication skills with clients and work colleagues an excellent multitasker.
Mary joined our office in 2012 and is our assistant administrator. She assists Fiona in the day to day running of a very efficient office. She is responsible for keeping the office running, the calendar right and assisting all other staff members with their projects and deadlines. She comes from a very experienced background in busy office environments with deadlines, quality and communication as priorities
On her time off Mary is kept busy with her very active teenage children, from Football/GAA runs, to Race Meetings and Show Jumping support. An active member of her community putting her organising skills to community projects.