Janet Worrell

Janet is a pharmacist with a PhD in medicinal chemistry, alumni Manchester and Strathclyde respectively. She has worked in Regulatory Affairs supporting drug development from scientific advice through early phase development (clinical & technical) to final dossier submission, via a number of significant changes within the regulatory environment Through Janet’s professional career she has supported applications in the UK/Europe/ASEAN and USA markets, covering medical devices, pharmaceuticals (OTC & ethical) and food supplements on a number of well-known brands.

Janet developed her regulatory skills working in the fast paced environment of generic medicines, working for Thomas Kerfoot & Sons and Medeva. She broaden her knowledge through European and Global requirements through management of 3M’s CFC free pressurised metered dose inhalers (Airomir™ & Qvar™). In order to gain insights into consumer understanding Janet supported a number of generic medicines into the Republic of Ireland for Boots and latterly the Strepsils™ brand across a number of markets (>120 territories). She was responsible for the introduction and approval of new flavours, products and maintaining compliance across a complex matrix of products. The opportunity to lead a European, then global team for Vectura plc, as the Director of Regulatory Affairs in inhaled medicines, lead to initiation of a number of scientific advice meetings and a deeper understanding of the clinical requirements within a dossier submission. Janet combined this role, with site operations for the Nottingham site, until its closure in 2010. Since this time Janet has explored a number of innovation opportunities both within Boots and externally. The understanding of a number of regulations permits exploration of opportunities within the overlapping boundaries of different product categories.

Janet’s key skills are: regulatory strategies to support innovation; ideas and product development); external collaboration; technical reviews and delivering the bigger picture in drug development.

Expertise
Regulatory, UK