Associate Director, Regulatory Affairs
Claire has extensive experience in Regulatory Affairs gained over the past 16 years. She is a seasoned project management and CMC professional. Claire has led and supported a wide range of product lifecycle maintenance, portfolio divestment activities, manufacturing site transfers and compliance activities. Claire has extensive expertise in working with EU and international affiliates / partners to support global regulatory programs. Claire has a wide range of experience across many therapeutic products including extensive OTC and medicinal product experience.
After joining BlueReg in September 2016, Claire has been responsible for lifecycle management for outsourced portfolios for national and MRP licences. More recently, she has acted as oversight manager for local in-country regulatory support programs for post-approval and launch preparation.
Prior to joining BlueReg, Claire was at PAREXEL for 11 years where her recent roles included project lead for large, geographically diverse, complex regulatory projects providing oversight of large project teams. Claire was responsible for allocating work, mentoring and performance of direct reports and project members to ensure projects were executed on time and in accordance with agreed budgets and client expectations. Whilst at PAREXEL, Claire had direct line management responsibility for Consulting staff. She has authored and reviewed numerous regulatory documents for submission (Marketing Authorisation Applications, variations and renewals) and performed many CMC compliance updates.
Prior to PAREXEL, Claire worked at Martindale Pharmaceuticals and GlaxoSmithKline supporting both
their European and International market activities.