Managing Consultant, tranScrip Regulatory, UK
Leslie has been a regulatory professional since 1997, working mostly as a regulatory consultant/team leader in the CRO/consultancy space, although she has also worked in pharma and a medical device company. She is currently Managing Consultant for tranScrip Regulatory, UK office. She has a special interest in early clinical phase development and has been Editor-in-Chief of Regulatory Rapporteur since 2011.
Executive Director, Global Regulatory Affairs, Gilead Sciences Int Ltd, UK
Davina has expertise in global regulatory strategy across the product lifecycle, and also process and system improvement. Her regulatory experience spans oncology, analgesia and liver disease therapeutic areas, orphan and generic drug development. Davina is a Chartered Scientist, TOPRA Fellow and holds a Regulatory Affairs MSc with focus on Regulatory Intelligence. Davina is Regulatory Rapporteur’s Deputy Editor and the Continuing Professional Development (CPD) Editor.
Principle Consultant, Jillian Stewart Regulatory Solutions, Ireland
Jillian has more than 15 years’ experience in regulatory affairs and quality, including more than 10 years working with a leading global generic pharmaceutical company. She has gained expert knowledge in both medical devices and pharmaceuticals – specialising in the Irish and Maltese markets in particular – and now operates as the Principal Consultant of Jillian Stewart Regulatory Solutions.
Vice President, Regulatory Affairs, Alan Boyd Consultants Ltd, UK
Julie has been involved in regulatory affairs since 2003, gaining significant pre- and post-authorisation experience in disease areas ranging from oncology to cardiovascular and infectious diseases. She has a special interest in advanced therapies, orphan drugs, oncology, clinical trials and marketing authorisations.
Senior Director, Regulatory Affairs, AstraZeneca, UK
Joan provides regulatory strategy and advice on global product development and marketing strategies, being involved in interactions with regulatory authorities worldwide to agree on a successful pathway. His area of focus is on oncology products, with expertise in advanced therapy medicinal products (ATMP) and biologics. He holds a PhD in biochemistry and molecular biology.
Regulatory and Communications Executive, Cyton Biosciences, UK
Pascale has worked at knoell for over ten years, overseeing regulatory procedures and carrying out regulatory intelligence research for clients in the animal health industry. She is also involved in knoell’s marketing activities, and has organised regulatory affairs training courses. With previous employment in publishing and educational environments, Pascale is currently a member of the TOPRA Editorial Board.
Senior Director, Regulatory Sciences, Voisin Consulting Life Sciences, US
As Senior Director Regulatory Science and Head of Complex Biologics at Voisin Consulting Life Sciences (VCLS), Michael (Mike) is responsible for providing both regulatory strategy and CMC consulting services to clients for global product development ranging from small molecule drugs to biologics and advanced therapies.
Head of Regulatory Affairs, Lysogene, France
Marie is in charge of defining and executing the regulatory strategy for the development and registration of Lysogene’s gene therapy products. Prior to joining Lysogene in 2019, Marie spent 15+ years in consulting. Involved in the development of biotech products, NCEs and repurposed drugs, Marie has extensive experience in interactions with FDA, EMA and national health authorities.
Executive Director, Head of Medical Devices & Combination Products, Organon & Co, UK
Steve has extensive experience in Healthcare Regulatory Affairs, Quality Assurance, Project Management, Design and Development. He is experienced in various medical technologies including drug/device combination delivery systems, borderline drug/devices, in vitro diagnostics/companion diagnostics, general medical devices, medical electrical equipment, software medical devices, digital health including apps, cosmetics, consumer health products and food supplements.
Head of Regulatory, CMC, Mundipharma, UK
Victoria graduated from university with a BSc in Chemistry with analytical science and began working as a quality control operative for ProSynth Ltd. She joined Mundipharma in 2021 as the Head of Regulatory chemistry, manufacturing and controls (CMC) and is responsible for the team providing regulatory CMC strategy across all the portfolios to maintain global compliance and support commercial opportunities.
Veterinary Medicines Consultant, KGVetMedConsultancy, Germany
Kornelia Grein has an extensive career which includes 20 years in management positions with responsibilities for veterinary medicines at the EMA. She currently provides services to the animal health industry and other organisations concerned with the development and authorisation of veterinary medicines as an independent consultant.
Director, Regulatory Policy & Intelligence, AbbVie
Esteban received his BSc in Biochemistry from Warwick University, a PhD in Virology from University College London, and his postdoc from Imperial College London. He has held a number of leadership positions, including Director of Regulatory Intelligence & Policy at Daiichi Sankyo Development Ltd, and Lead for Pharmacovigilance & Regulatory Affairs at ABPI.
Regulatory Affairs Director, Healx Limited, UK
Richard (Regulatory Affairs Director, Healx) has 30 years’ experience in drug development coming from pharmaceutical, biotech and CRO industries. Healx leverage artificial intelligence technologies in drug discovery to develop new treatments for rare diseases. Prior to Healx, he was a Senior Director for Huron (Pope Woodhead), with CROs PPD and Gregory Fryer Associates, managing global clinical trial submissions and lifecycle strategy. He has also managed teams at Actelion, Axovan (Basel), Chiroscience and he has authored 30+ peer-reviewed publications.
Vice President, Regulatory Affairs, F-star Therapeutics Ltd, UK
Patricia Hurley PhD is Vice President and Head of Regulatory Affairs at F-star Therapeutics. She is responsible for overseeing the regulatory strategy for F-star’s innovative bispecific antibodies in immuno-oncology. As a pharmacologist by training, she spent several years in the global CRO and regulatory product development space.
Regulatory Intelligence Associate Director, Accenture, US
Leah’s function is Life Sciences and Regulatory Intelligence within Accenture’s Life Sciences practice, with over 20 years of experience. Leah monitors the Life Sciences regulatory environment for regulations, innovations and trends. Leah previously worked for global pharmaceutical companies in regulatory and has deep technical experience in electronic submission standards.
Senior Director, Regulatory Affairs, PPD Global Ltd, UK
James is a Senior Director in regulatory affairs and with more than 40 years of experience in research and development, he supports clients across the full spectrum of regulatory development. He mentors staff and clients with the delivery of their development strategies and maximisation of the global market.
Director, Regulatory Affairs, Touchlight Genetics, UK
Satish has 16 years of experience covering development and lifecycle maintenance of both small and large molecules. He is currently supporting the development of nucleic acid-based vaccines and provides CMC regulatory advice for partners to enable the utility of doggybone DNA technology in vaccines and advanced therapy applications.
Regulatory Affairs Manager, Head of Regulatory Affairs UK & Ireland, Bausch + Lomb, UK
Sobhey is Head of Regulatory Affairs at Bausch and Lomb, managing the activities of a large portfolio of products authorised in the UK and Ireland, as well as having Medical and PV oversight. He has extensive industry experience, having worked in a number of manufacturing site, regional and global roles. Sobhey has been a member of TOPRA since 2006 and joined the Editorial Board in early 2014.
Senior Director, Global Regulatory Affairs, PPD, Ireland
Ilse-Maria is Senior Director of Global Regulatory Affairs at PPD, leading PPD’s Regulatory Intelligence, Policy & Advocacy function. She is an Industrial Microbiologist and Pharmacologist by training with extensive industry experience from her time in pharmaceutical and contract research organisations. Ilse-Maria is a long-standing member of TOPRA and joined the Editorial Board in 2020.