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Clinical Research and Regulatory Affairs

Science & Mathematics

Duration

2 years

Level

Postgraduate

Outlook

Growing

What will you learn?

This MSc prepares you for the specialised world of clinical trials and regulatory science, covering the full lifecycle of medicines and medical devices from trial design through to market authorisation. You study Good Clinical Practice (GCP), biostatistics, pharmacovigilance, and the EU regulatory framework governing medicinal products and medical devices. Modules are grounded in real-world practice, and you typically complete a research project or placement with a contract research organisation (CRO), pharmaceutical company, or medtech firm. A typical week combines lectures, case-study workshops analysing regulatory dossiers, and online collaboration with industry professionals. You develop transferable skills in scientific writing, regulatory strategy, and clinical data management that are directly applicable to Ireland's thriving life sciences sector.

Required Education

Entry to this NFQ Level 9 programme normally requires an NFQ Level 8 Honours Bachelor degree (minimum 2.2) in a relevant discipline such as pharmacy, biochemistry, nursing, biomedical science, medicine, or a related health or science field. A background in Higher-level Biology, Chemistry, or Mathematics at Leaving Certificate is useful preparation for undergraduate entry but entry to this postgraduate programme is assessed primarily on your undergraduate qualification and, where relevant, professional experience. Applicants with significant industry experience in clinical trials, regulatory affairs, or a health sciences setting may be considered under a mature or experiential-learning route depending on the institution. Some programmes accept graduates from non-science disciplines such as law or business if they can demonstrate relevant professional exposure to the life sciences sector.

Core Subjects

Career Prospects

Ireland's life sciences sector is one of the most significant in Europe, and demand for professionals with combined clinical research and regulatory expertise remains consistently strong. Graduates with GCP certification and EU regulatory knowledge are particularly sought after given Ireland's role as a base for major global pharma and medtech companies. Starting salaries for regulatory affairs and clinical research roles in Ireland typically range from approximately €40,000 to €55,000 gross per year, rising considerably with experience and specialisation. Career progression to senior regulatory manager, clinical operations director, or QA lead is achievable within five to ten years.

Impact of AI on this program

Artificial intelligence is increasingly being used in clinical trials to accelerate patient recruitment, monitor safety signals in real time, and analyse large datasets generated during trials, reducing timelines and costs. Regulatory bodies including the European Medicines Agency (EMA) and the HPRA are developing frameworks for AI-assisted submissions and AI as a medical device, creating a new and growing area of regulatory expertise. As a graduate in this field, you will need to understand AI-generated evidence and how it is assessed under existing regulatory pathways. Rather than replacing regulatory and clinical research professionals, AI is expanding the scope and complexity of the work, making specialist human judgement more rather than less important.

Where can you study this?
Verified 2 days ago

Trinity College Dublin

Dublin

TU Dublin

Dublin

University College Dublin (UCD)

Dublin

University of Limerick (UL)

Limerick

National University of Ireland Galway (University of Galway)

Galway

Royal College of Surgeons in Ireland (RCSI)

Dublin

Technological University of the Shannon (TUS)

Limerick / Athlone

How to apply

This is a postgraduate taught programme; applicants apply directly to each institution's postgraduate admissions office, typically requiring an honours primary degree (NFQ Level 8, minimum 2.2) in a relevant science, pharmacy, nursing or health-related discipline. The CAO system is not used for postgraduate entry.

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