Current position and relevant professional experience:
Director of Regulatory Affairs and Pharmacovigilance and member of the executive management team at Porton Biopharma Ltd., a company with special focus on pediatric oncology and vaccines.
I have over 25 years’ experience in global regulatory affairs at a senior level across diverse business and cultural settings from the bio-pharma and CRO industry. My career has provided me the opportunity to gain extensive operational, strategic and leadership experience across the full spectrum of product development including regulatory, pharmacovigilance, market access and lifecycle management.
An active industry advocate and thought leader, I pursue opportunities to proactively advance the regulatory paradigm. My role as a prior TOPRA Board member (2018-19) provides a strong foundation on which to contribute immediately if selected for the role of President-Elect.
My professional profile includes Chartered Chemist status, Fellow of the Royal Society of Chemistry; Fellow of the Chartered Management Institute and Member of TOPRA. My educational foundation includes a PhD in analytical chemistry from the University of Hull, a diploma in management at The Open University and a validated diploma in management studies from the Institute of Management.
Current or previous involvement in TOPRA activities:
I have been a member of TOPRA since the start of my regulatory career (including BIRA & ESRA). Over the years, I have benefitted from training and development via TOPRA and grown my volunteer contribution to the organisation, including provision of articles in Regulatory Rapporteur and various SPIN groups.
As a leader keen to ensure development of others, I have also encouraged and facilitated team contributions to many aspects of TOPRA.
After attending the first TOPRA SUMMIT meeting, I joined the SUMMIT organising committee and consequently have helped to shape all subsequent meetings. This includes content and delivery planning, co-leading ‘Debate and Impact’ session/workshops at each event and contributing to the published meeting reports.
As a TOPRA Board Director for the period 2018-2019 I participated in developing the current strategy and vision for the organisation. I was particularly honoured to be the Board representative at the joint ARAP & TOPRA Indian and European Regulatory and Quality Summit, New Delhi, India and delivered the presentation ‘Thriving in a Globalised Regulatory Environment - Considerations for Regulatory Affairs’.
Personal statement:
I am grateful to have previously served the TOPRA Board and understand the role it plays governing activities that TOPRA undertakes on behalf of its members and stakeholders.
My passion is influencing change to improve health equality worldwide, so patients and consumers live longer healthier lives. Recent events illustrate that proactivity, collaboration, and solution orientated mindsets can ‘make a difference’. Regulatory professionals are in a unique position to champion new approaches for the benefit of all.
As President-Elect I would leverage my background to enable the TOPRA Strategy and enthusiastically ensure evolution with the ever-changing environment in which we operate.
Nomination information
Proposer: Anne Nallen; Seconders: Evgenia Mengou, Shaila Choi