Editorial Board

Davina Stevenson

Executive Director, Inspection Management & Intelligence
Implementation, R&D Quality, 
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.


Victoria Goff
Deputy Editor

Head of Marketed Products and 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. Joined Mundipharma in 2021 as
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.

Harriet Edwards
Deputy Editor

Associate Director, Regulatory Affairs,
Alan Boyd Consultants Ltd., UK

Harriet held at Albumedix senior positions including Head of Regulatory Affairs and most recently joined the regulatory team at Boyds Consultants. She holds MSc’s in both Pharmacology and Regulatory Affairs and is published articles in professional journals. She won the TOPRA Regulatory Excellence Award, Regulatory Communications, in 2021.

Joan Boren

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 ATMP
and biologics. He holds a PhD in biochemistry
and molecular biology.

Mike Day

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.

Kornelia Grein

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.

Esteban Herrero-Martinez

Director, Regulatory Policy & Intelligence,
AbbVie, UK

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.

Richard Huckle

Regulatory Affairs Director, Healx Limited, UK

Richard has 30 years’ experience in drug development coming from pharmaceutical, biotech and CRO industries. Healx leverage AI technologies in drug discovery to develop new treatments for rare diseases. Prior to Healx, he was a Senior Director for Huron, and CROs PPD and Gregory Fryer Associates, managing global RCT submissions and lifecycle strategy. He has also authored 30+ peer-reviewed publications.

Patricia Hurley

Vice President, Regulatory Affairs and Quality, invoX Pharma.

Patricia has over 15 years’ experience in regulatory affairs and product development gained in consulting at PPD (a global contract research organization) and F-star Therapeutics. She holds a B.Sc. (Joint Hons) in Molecular Genetics and Pharmacology and a Ph.D. in Pharmacology from University College Dublin, Ireland.

Leah Kleylein

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.

James McCormick

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.

Satish Muchakayala

Director, Regulatory Affairs,
Touchlight Genetics, UK

Satish has 16 years of experience covering development and lifecycle maintenance of both small and large molecules. Currently he supports 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 ATMP applications.

Sobhey Nassar

Head of Regulatory Affairs,
UK, Ireland & Nordics, Bausch + Lomb, UK

Sobhey manages 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, joining TOPRA in 2006 and the journal’s Editorial Board in 2014.

Ash Ramzan

Principal Consultant & Founder,
Woodley BioReg, UK

Ash has expertise in the manufacture,
testing, release, and global registration of
pharmaceutical and biopharmaceutical
products;including life cycle management/
maintenance and product conformance.
He is also has specialist expertise in
vaccines and biological products
including biosimilars.

Sarah Roberts-PRAHS

Sarah Roberts

Vice President and Head of Global Regulatory Affairs,
PRA Health Sciences

More than 20 years experience in oncology research, pharmaceutical and contract research industries. In depth understanding of the regulatory processes and environment across more than 60 countries. ACRO Scientific and Regulatory committee since 2006 and President of TOPRA 2014-2016. MBA graduate - Regulatory Strategy, Henley Management College. 

Marie Uguen

Senior Vice President, Regulatory Affairs and Quality Assurance, SparingVision, France

Marie leads on regulatory strategy for SparingVision’s ocular diseases ATMP pipeline and also heads its QA department. Previously Marie held a similar position at Lysogene. Marie has been extensively involved in biotech development, NCEs and repurposed drugs with considerable interactions with the FDA, EMA and national health authorities.

Julie Warner

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.


Birgit Roser

Birgit has worked in the pharmaceutical industry since 2001, as a consultant in the field of regulatory affairs, quality assurance, GMP/GDP, clinical trials, pharmacovigilance, the medical device sector and preclinical area. She also works as a QPPV in veterinary medicine, as information manager and as an animal welfare officer. In addition to her role as a Consultant Editor on Regulatory Rapporteur’s Editorial Board, Birgit is also a member of TOPRA’s Veterinary Medicines Special Interest Group (Vet SPIN).


Nancy Pire-Smerkanich

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.