Kelly Taylor

Global Regulatory Affairs Liaison in the Inflammation and Respiratory team. Product lead for developmental product being studied for use in patients with NASH (Phase 2) and IPF (early phase 1). Providing regulatory guidance & leadership to ensure that the product deliverables are completed on schedule in line with TA strategy, milestones and regulatory requirements; working with global regulatory leads to ensure effective communication both to and from project teams and to develop global regulatory strategies and registration plans; acting as a key connector between the different areas of the business. Building and maintaining strong relationships with Gilead’s collaborative partner in the NASH space.

European Regulatory Affairs department working in the Oncology therapeutic area. Leading the preparation and project management of type II variations for a mutual recognition product; coordinating product information updates, publishing and parallel affiliate submissions to concerned member states. Leading filing strategy and preparation of two first in human fast lane clinical trial for bispecific single chain Tcell Engager (BiTE®) antibody constructs, in the treatment of adults with relapsed and/or refractory multiple myeloma and Non-Hodgkin’s lymphoma.

International Regulatory Affairs Liaison in Inflammatory and Liver Disease areas. As part of a team managing large pivotal phase 3 clinical trials running across the EU and rest of world for a developmental drug in rheumatoid arthritis. I worked across the chronic Hepatitis C portfolio; leading pivotal phase 3 trials to the MAA, post-marketing commitments and paediatric clinical trials in relation to the Paediatric Investigation Plan for the product. I supported product leads for marketed and development products, overseeing the entire lifecycle; PIP preparation and submissions, MAA preparation, filing to post-authorisation maintenance (variations), product information maintenance and translations. I was a EudraVigilance and Medicinal Product Dictionary (EVMPD) coordinator and the Deputy Chair of the Internal Clinical Trials User Group within Gilead.

Full-time position. Responsible for scanning, analysing and distributing EU regulatory intelligence and other pharmaceutical related information throughout the company; answering a wide range of intelligence queries for colleagues covering product specific and industry related questions and producing the team newsletter for circulation to a wide audience within the company. Maintaining effective communication with colleagues on a global level and demonstrating teamwork and problem solving skills. Ability to self-motivate and keep to deadlines to complete the work required. Capability to adapt to large changes within the company and handle being sole site representative for my department.