Vice President (Technical)
Parexel
Parexel Vice President (Technical) and former Pharmaceutical Assessor at the Medicines and Healthcare products Regulatory Agency (MHRA) with over 10 years of experience in working in CMC and regulatory affairs, including six years licensing medicines at the Agency.
Assessment work performed for MHRA entailed national and EU initial applications which covered DCPs, MRPs, centralised (Rapp and Rapp peer reviewer) and the assessment of NCEs. Also reviewed IMPDs as part of Clinical Trial Applications. Part of team which helped to establish the MHRA Innovation Office as an entry point for early stage regulatory advice for innovative products and methodologies, and was the UK representative for the growing EU Innovation Network chaired by the EMA Innovation Task Force.
As a Vice President (Technical) at Parexel has helped clients prepare their CTA/IND, MAA/NDA and variation submissions as a CMC Subject Matter Expert (SME) and provided regulatory, strategic and technical input for lifecycle activities in European and international markets. In addition, helps prepare questions and briefing packages for clients for regulator advice meetings and attends on their behalf.
RAPS publications:
-Global Pharmaceutical and Biologics Regulatory Strategy, second edition. Chapter 7 CMC Regulatory Strategy
-Fundamentals of EU Regulatory Affairs, eighth edition. Chapter 28 Generic Medicinal Products
-Quality Management Systems for Drugs and Devices. Chapter 17 CMC Regulatory Strategy
Disclosure information not submitted.
Monday, September 12, 2022
4:35 PM – 5:30 PM MST