Michael McDonald

International and Policy Executive at Health Products Regulatory Authority (HPRA)

Dublin, County Dublin, Ireland

About

I'm a regulatory professional with over 10 years' experience spanning a wide breadth of regulatory frameworks for health products. Having completed a PhD in the life sciences, I have since progressed through several roles at the HPRA. Initially I worked in the area of safety monitoring of medicines, first veterinary and then human, before moving to a role in which I provided technical and strategic support to the HPRA's Chief Executive. I now focus on international and regulatory policy development, helping to shape organisational positions on national and EU legislation, coordinating cross‑organisation initiatives, and supporting senior leadership in the delivery of strategic regulatory priorities. I represent the HPRA across a number of national and international networks, including as the Irish delegate to the EU Innovation Network, supporting the advancement of innovative medicines and emerging technologies.

Experience

  • Health Products Regulatory Authority (HPRA) (10 yrs 6 mos)
    • International and Policy Executive
      Feb 2026 - Present · 6 mos

      As International and Policy Executive I am responsible for the development and delivery of international and regulatory policy initiatives at the HPRA, shaping organisational positions on national and EU legislative developments. My work spans strategic development of regulatory policy, cross‑organisational coordination, and high‑level stakeholder engagement, including with government, national partners, and international regulatory networks. I prepare strategic briefings and materials for the Chief Executive and senior leadership, support implementation of key regulatory reforms, and represent the HPRA across a range of policy, regulatory, and innovation forums. I am also the Irish delegate to the EU Innovation Network, a joint venture between the Heads of Medicines Agencies network and the European Medicines Agency that supports development of innovative medicines and associated technologies.

    • Executive Assistant to the Chief Executive
      Feb 2023 - Jan 2026 · 3 yrs

      In this role I provided technical and strategic support to the Chief Executive of the HPRA, encompassing the full breadth of the organisation's regulatory remit. This included coordination of, and communication on, projects and initiatives at cross-organisational, national, and international levels. Examples of such initiatives include projects executed under the International Coalition of Medicines Regulatory Authorities (ICMRA) and the Heads of Medicines Agencies (HMA), including development and implementation of the strategy for the European medicines regulatory network.

    • Pharmacovigilance Surveillance Assessor
      Sep 2020 - Feb 2023 · 2 yrs 6 mos

      As Pharmacovigilance Surveillance Assessor I led the team responsible for review and evaluation of individual case safety reports (ICSRs) associated with medicines used in both the pre- and post-marketing setting, and I was responsible for oversight and management of the national database of reports of suspected adverse events. I was responsible for ensuring that ICSRs submitted to the HPRA were processed in line with the relevant EU guidance and within legislative timelines.

  • Member of the Pharmacovigilance Working Party - Veterinary at European Medicines Agency
    Nov 2018 - Apr 2019 · 6 mos

  • Trinity College Dublin (4 yrs 3 mos)
    • Problem Based Learning Tutor
      Oct 2014 - Dec 2015 · 1 yr 3 mos

      Facilitating, mentoring and evaluating the performance of first year medical students in physiology, biochemistry, anatomy and medical ethics case studies.

    • Laboratory Teaching Assistant
      Oct 2011 - Dec 2015 · 4 yrs 3 mos

      Responsible for communicating and demonstrating practical laboratory work to medical, dentistry, physiotherapy and natural sciences undergraduate students.

    • Educational Support Worker
      Mar 2012 - Oct 2015 · 3 yrs 8 mos

      Subject specific tutor in physiology for students that required additional learning support.