Vice President - Technical, Parexel Consulting (PC).
Parexel International
I possess over 20 years experience in the biopharmaceutical industry across the drug development lifecycle, from basic biomedical research and biomarker development to quality control and CMC/regulatory affairs for various types of biological products including biosimilars, monoclonal antibodies, recombinant proteins, vaccines, and low molecular weight heparin products.
Since joining Parexel in April 2021, I have been supporting our Clients as a Subject Matter Expert on the CMC of Biological Medicinal Products and Regulatory Affairs both at the pre- and post-authorization stages of Clinical Trial and Marketing Authorization procedures, with an EU and US focus.
Prior to that, I was six years as a Pharmaceutical (CMC/Quality) reviewer of Biological Medicinal Products at the Health Products Regulatory Authority (HPRA) in Ireland. In brief, I acted as a reviewer (rapporteur / co-rapporteur) of CMC for human biological medicinal products submitted via EMA centralized marketing applications route, post-authorization variations and in the evaluation of IMPD's for Clinical Trial Applications (CTAs). I also acted as coordinator on national and EMA scientific advice procedures related to the CMC aspects of biologics.
I have a history as a strong research professional skilled in biomedical research with a proven track record in funding and publishing.
Friday, May 8, 2026
12:30 - 13:30 WEST