Current position and relevant professional experience:
I hold the position of Vice President, Regulatory Science, Strategy & Innovation at Worldwide Clinical Trials, a global CRO. I’ve been in Regulatory Affairs in the CRO space for over 26 years.
I provide 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. Passionate about helping to develop comprehensive regulatory strategies, I help sponsor companies achieve their end-to-end regulatory strategies from study submission to commercialization.
I am equally enthused about the "people" aspect of healthcare as well as strategic operations in building, engaging and retaining teams and how this translates to successful product development and maintenance.
An advisor, healthcare board member and mentor in industry, I have a deep interest in how innovations continue to evolve industry, and how regulations, ethics and compliance will continue to have a loud voice at the healthcare table.
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 plus 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, participated in North America activities.
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 am honoured to serve as a member of the judging panel for the awards.
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 including a board member role.
I would be honoured to serve as President-Elect that in turn serves TOPRA members and elevates the Regulatory profession.
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: Sarah Bly; Seconders: Hasnaa Fatehi, Liz Madichie