David Murray, Ph.D.

BIO

David Murray, Ph.D.

Vice President, Technical – Regulatory Consulting

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David has more than two decades of experience in the biopharmaceutical industry across the entire drug development lifecycle, from research and biomarker development to quality control and regulatory affairs. At Parexel, David is a subject matter expert on regulatory affairs and the chemistry, manufacturing and controls (CMC) of biological medicinal products. He supports customers at the pre- and post-authorization stages of clinical trial and marketing authorization, in Europe and the US. 

Work experience
David joined Parexel in 2021 after working at the Health Products Regulatory Authority (HPRA), Ireland as a Pharmaceutical (CMC/Quality) Assessor of Biological Medicinal Products. David was also:

  • A reviewer (Rapporteur / Co-Rapporteur) of CMC for human biological medicinal products submitted via EMA centralized marketing applications route as well as and post-authorization variations 
  • Coordinator on EMA scientific advice procedures related to CMC aspects of biologics, for various types of biological products including biosimilars, monoclonal antibodies, recombinant proteins, vaccines, and low molecular weight heparin products
  • The Irish delegate at numerous EMA CHMP Biologics Working Party (BWP) meetings and at CHMP annual influenza update meeting and a member of BWP vaccine core group

Education 

  • BSc (Hons) in Analytical Science. Dublin City University (DCU), Dublin, Ireland
  • Ph.D. in Cancer Cell Biology, DCU, Dublin, Ireland
  • 10 Years Experience Post-Doctoral Research & Teaching