Current position and relevant professional experience:
I hold the position of Global Head of Regulatory Strategy at Worldwide Clinical Trials, a mid-size global CRO. I joined Worldwide from a large global CRO, where during my 17 year tenure, I led and developed many functions and services within Regulatory Affairs, such as a regulatory intelligence function and developing a Regulatory Strategy group.
I have a 23-year track record of success within the CRO environment in providing global strategic direction in regulatory affairs, having led a wide variety of regulatory projects providing regulatory strategy and development services for a variety of client sponsor companies ranging from virtual companies to large companies in many therapeutic indications.
I am passionate about helping sponsor companies develop comprehensive regulatory strategies. My career is built on helping sponsor companies achieve their end to end regulatory strategies from study submission to commercialization.
I am equally enthused about the "people" aspect of business as well as strategic operations in building, engaging and retaining teams and how this translates to successful product development and maintenance.
Current or previous involvement in TOPRA activities:
I am a Medical Biochemist by background and turned to a career within Regulatory Affairs soon after graduating from Brunel University. I have been a member of TOPRA (formerly BIRA) for over 20 years, continuing to retain my membership when I moved from the UK to Canada. Having moved countries, I also continued to be a member of the Regulatory Rapporteur editorial panel for a period, previously having been a member of the editorial panel of the BIRA journal.
I have been an active member of the TOPRA in North America for over 10 years, currently co-chair of the North American Leadership team of TOPRA, having been chair for over 3 years. I am also a member of the TOPRA Diversity Committee where I provide my experiences and expertise as a diversity, inclusion and belonging champion to drive forward initiatives for members, with TOPRA being a signatory to the Science Council's Diversity Declaration.
In 2017, I was nominated and shortlisted for the TOPRA Regulatory Excellence awards under the Inspiration category and for the past two years am honoured to serve as a member of the judging panel.
Volunteering in TOPRA is something that has been important to me and continues to be important to me. Not only have I had the opportunity to learn, network and knowledge share but I am able to help shape the future of regulatory affairs and provide expertise and experience to early career regulatory professionals.
Personal statement:
I am humbled to work in a profession that allows me to play a part, alongside fellow regulators, to make a difference for humanity through positive developments in healthcare.
Over the years, I have volunteered with TOPRA in various capacities and I would be honoured to serve as a TOPRA board member in North America to continue driving forward TOPRA’s Strategic Plan.
I want to help bring forward, the voices of TOPRA members so that TOPRA is able to serve members needs effectively with training, development and future skill growth for the coming years in the regulatory profession.
Nomination information
Proposer: Natalie Tolli; Seconders: Gillian Ivers-Read, Peter Lassoff