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 Creed is a co-founder and Managing Director of Real Regulatory. His main talents lie in running the business administration aspects of the company and indeed Paddy has been a director of other SME size companies that have achieved significant growth during his tenure. At Real Regulatory Paddy has driven the business from start up to in excess of €2.5 million turnover company employing 18 people.

As Managing Director Paddy’s responsibilities include strategic development of the company, human resources, accounts, business expenditure and oversight of the Quality and IT systems.

Paddy Creed
Managing Director

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.

Karen Real
Director

Dorothée joined the company in May 2006 and has worked in regulatory affairs since 2003 mainly in human medicinal product, including small chemical entity and biotechnology products. Previously Dorothée was part of the CMC regulatory team at the manufacturing site of a major pharmaceutical company.

Dorothée’s current role is as Managing Consultant of the Irish office.

As part of the management team Dorothee has managed projects through the full product lifecycle from early development to product maintenance and MAH compliance. She has also supported several clients in preparation of inspection readiness. Dorothée oversees and manages our Irish office whilst providing expert consultancy to her client projects.

Dorothée Fouchier
Managing Consultant
(Ireland)

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.

Lucy Herlihy
Regulatory Affairs Manager

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.

Fiona Windsor
Office Manager

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.

Michelle Gafa
Managing Consultant
(Malta)

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.

Leslie Dowling
Managing Consultant
(United Kingdom)

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.

Mary McDermott
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.

Niamh Miller
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 position within the company is to provide support for a variety of international clients.

Tessa’s current role in the company is as Regulatory Affairs Consultant.

Tessa Fiorini-Cohen
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.

Catherine Parker
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.

Tanya Rackstraw
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.

Claire Corinne Azzopardi
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.

Marthese Mifsud
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.

Louise Spencer
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.

Cristiana Suciu
Regulatory Affairs Consultant

Stephanie joined the company in October 2019 and has worked in regulatory affairs since 2016. She has over 5 years’ experience in the generic pharmaceutical industry and has held roles in analytical research and development and in CMC regulatory affairs. Her position within the company is to provide regulatory support to our consultants in the preparation of regulatory submissions.

Stephanie’s current role in the company is as Regulatory Affairs Associate.

Stephanie Allampalli
Regulatory Affairs Associate

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.

Michael Edwards
Senior Regulatory Affairs Consultant