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.
Karen was a co-founder of the company in 2002. Involved in the pharmaceutical industry since 1994, she has been employed in compliance and regulatory positions within both the generics and ethical medicines industries, and in a Contract Research Organisation.
Now in her 19th Year of running the regulatory function in Real Regulatory, Karen has extensive experience in all aspects of the life of a medicine, from development strategy, CTs, and gaining approvals and lifecycle management for MAAs in Europe. As a Director, she is also responsible for team management, business development and the service realization process. Over the years Karen has built an expansive network within the global pharmaceutical industry.
Louise Boppert joined the company in June 2022. As Managing Consultant in charge of the Dublin Office Louise manages a team of professionals in the areas of pharmaceuticals and medical devices. She has worked in the pharmaceutical industrial since 2006 and has consultancy experience in Regulatory Affairs and Pharmacovigilance in both clinical development and marketing authorization. Louise is experienced in managing multiple regulatory projects simultaneously, working in matrix organisations, both within small pharma (i.e., SME) and as consultant/CRO for medium to large pharma clients.
In her previous roles she has gained pharmaceutical experience in the area of biologicals (i.e., COVID-19 anti-spike antibodies) and new chemical entities (i.e., dermatology and ophthalmology) from clinical development, through to marketing authorisation and life-cycle activities. She has also considerable experience in Pharmacovigilance, including the set-up of a European PV system for a US based Company and has also functioned as a head of regulatory for an small pharmaceutical company.
Louise holds a Ph.D. in Molecular Science from the Institute for Toxicology, Johannes Gutenberg-Universität in Mainz, Germany. She has a Masters in Drug design and biomedical Science and a Honors degree in Toxicology.
Louise is also a member of both the TOPRA and RAPS regulatory associations.
Lucy joined the company in Sept 2010, having worked in EU regulatory affairs since 2007 in human medicinal products, including MAAs, product portfolio maintenance for centralised and national products, CT regulatory support and project management, within consultancies specialising in pharmaceutical regulatory affairs. Previously Lucy was a senior clinical trial manager within a CRO. Lucy has pharmaceutical regulatory experience in a variety of therapeutic areas including oncology, neurology, respiratory, gastrointestinal and cardiology.
Lucy’s current role is as Regulatory Affairs Manager. Part the management team, Lucy is key to developing and maintaining relationships with clients and providing support and training to other employees.
Fiona joined the company in 2011, bringing with her 20 years of experience in administration throughout various industries. Previous experience includes retail, wholesale distribution and manufacturing industry.
She maintains an excellent relationship with our consultants as well as working on the company’s marketing and business development along with ensuring our ISO 9001 quality standard is maintained.
Fiona’s current role in the company is Office Manager and ISO document controller.
Michelle joined the company in June 2015 and has worked in regulatory affairs since 1996. Her background is in human pharmaceuticals, with 18 years’ experience in the pharmaceutical industry, moving to consultancy in 2014.
Michelle’s current role in the company is Managing Consultant in charge of the Malta office.
Michelle is part of the management team of the company. Her main expertise is in chemistry, manufacturing, and controls (CMC), marketing authorisation procedures, regulatory intelligence, and project management. Responsibilities include management of the Malta team while providing expert input to clients.
Leslie joined the company in April 2017 and has worked in EU regulatory affairs since 1997 mainly in human medicinal products, including advanced therapies and clinical regulatory support, both within small/medium pharma and as consultant/CRO with small to large pharma clients.
Leslie’s current role is as Managing Consultant in charge of the UK office, managing a growing team of consultants whilst providing expert consultancy to client projects.
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 has experience in a variety of therapeutic areas including gene therapy, oncology, neurology and respiratory.
Mary joined the company in September 2012 having worked in administration for a number of years previously. Previous experience includes office equipment, retail, refrigeration, and lighting industry. Mary is integral to the day to day running of the office.
Mary’s current role in the company is as Office Administrator.
Niamh joined the company in June 2016 having spent 15 years working in quality compliance in the medical device sector initially as a QC Supervisor(2 years) before being promoted to QC Manager. Niamh also worked in the pharmaceutical sector from 1990 -2000 in both R&D (method development) and as a QC Chemist in a bulk pharmaceutical manufacturer.
Niamh’s current role in the company is as Regulatory Affairs Consultant.
Tessa joined the company in July 2016 and has worked in regulatory affairs since then. Tessa’s previous experience includes quality assurance, process and cleaning validation, and analytical development within the pharmaceutical industry, as well science communication within academia and media.
Tessa’s current role in the company is as Senior Regulatory Affairs Consultant.
Catherine joined the company in September 2016 and has almost 20 years’ experience working in the pharmaceutical industry including experience in CTs, MAAs and product portfolio maintenance. She has worked in the areas of OTC , ATMP, innovator and generic medicines and has experience in centralised, MRP, DCP, variation grouping, work-sharing, and national procedures.
Catherine has worked for several large generic and innovator pharmaceutical companies as well as a large multinational CRO. She has worked in regulatory affair positions in Europe, New Zealand and Australia and has experience making submissions in the Middle East, Japan and US.
Catherine’s current role is as Senior Regulatory Affairs Consultant.
Tanya joined the company in June 2017 and has worked in regulatory affairs since 2002, in a number of different types of organisation, including a UK national regulatory agency, pharmaceutical company, regulatory affairs consultancies and a medical writing consultancy.
Tanya’s current role in the company is as Senior Regulatory Affairs Consultant.
Claire Corinne joined the company in October 2017 having worked in regulatory affairs since 2000. Claire’s previous experience in the pharmaceutical industry includes Chemistry, Manufacturing and Control (CMC), EU regulatory affairs, supporting pharmaceutical development from a regulatory perspective, Module 3 audit, risk assessment, gap analysis and upgrading, dossier compilation (Modules 1, 3 and QOS), responding to CMC deficiency letters, life cycle management and also project and team management.
Claire’s current role in the company is as a Senior Regulatory Affairs Consultant.
Marthese joined the company in March 2019. She has worked in administration for a number of years.
Previous experience includes administrative work within a Regulatory Affairs Department at a pharmaceutical company, and other sectors ranging from maritime pollution to the Office of the Ombudsman and also to culture and education.
Marthese’s current role in the company is as Office Administrator.
Louise joined the company in March 2019 and has worked in regulatory affairs since 2001, mainly in human medicinal products, including pre-submission activities, marketing authorisation applications, product portfolio maintenance for centralised and national products, clinical trial regulatory support and project management but also veterinary medicinal products. Louise has worked both as a regulatory consultant and for a small pharmaceutical development company.
Louise’s current role in the company is as Senior Regulatory Affairs Consultant.
Cristiana joined Real Regulatory in August 2019 and has worked in regulatory affairs and administration since 2017. Her experience includes post-marketing lifecycle management activities for national and European licences and advertising in the UK and Ireland gained from her previous roles in human pharmaceutical industry settings.
Her current role in Real Regulatory is as Regulatory Affair Consultant.
Stephanie joined the company in October 2019 and has worked in regulatory affairs since 2016. She has 6 years’ experience in the generic pharmaceutical industry and has held roles in analytical research and development and in chemistry, manufacturing and controls (CMC) regulatory affairs.
Stephanie’s current role in the company is as Regulatory Affairs Consultant.
Michael joined the company in May 2020 and has worked in regulatory affairs since 2000 (with a break for obtaining a post-graduate qualification). Previous experience includes work primarily on human medicinal products, including clinical trial authorisation and maintenance, pre-submission activities for marketing authorisation, and marketing authorisation application and maintenance using national and European procedures; and also, some experience with veterinary medicinal products. Michael initially joined a UK national regulatory authority but has since worked as part of regulatory consultancies and pharmaceutical companies, and also as an independent consultant.
Michael’s current role is as Senior Regulatory Affairs Consultant.
Trisha has worked in regulatory affairs since 2008 and has 13 years’ experience in Regulatory Affairs, specifically in the medical device industry. She has worked for numerous medical device manufacturers both in Europe and the US, covering a vast array of medical devices portfolios, from breast implants, obesity products, wound care, acute care, patient care and orthopaedic products. In her previous positions, she specialised in European Regulatory Affairs, CE marking a diverse range of medical devices, from Class I through to Class III, in addition to completing regulatory submission in various international markets.
Trisha has also had considerable experience in the development and maintenance of technical files for medical devices, including ERC, GSPR and the coordination of CERs, in addition to the participation of internal and notified body audits for ISO 13485, MDSAP and the Medical Device Directive.
Laura has worked in regulatory affairs since 2015 specifically in the medical device industry. She has worked for an orthopaedic medical device manufacturer with products sold globally. In previous positions, she specialised in quality management systems, medical writing including technical files and clinical evaluations reports, risk analysis, management of post market surveillance and CE marking medical devices, from Class I through to Class IIb implantable. Also managing Notified Body audits covering MDD, MDR, ISO 13485, UKCA, MDSAP markets, FDA CFR 820 and Canadian Medical Devices Regulations.
Prior to making the move to the medical device industry, Laura worked in quality management for a UK university. She has a degree in life Sciences (BSc) and post-graduate master’s degree (MSc) in Strategic Quality Management.
Catherine has worked in Quality Assurance since 1987 then, in 1993, began to focus on Regulatory Affairs for medical devices. She has worked for companies with manufacturing in Europe, US and Asian markets covering many categories of medical device and other product portfolios from orthopaedic implants, first aid and wound care, consumer healthcare and aesthetic devices. CE marking medical devices from Class I through to Class III, cosmetic products, non-medical electrical devices along with completion of regulatory submissions and approvals in many international markets.
Working on all aspects of regulatory device submissions, under both MDD and MDR including product development, product changes, vigilance, post market surveillance, ISO 13485, MDSAP, KGMP, BGMP, Taiwan QSD.