International Regulatory Affairs - Waterford

Lectures will be used to introduce the concepts involved in International Regulatory Affairs as well as an in-depth investigation into the area. Additionally, the core concepts behind legislation and regulation in the pharmaceutical and healthcare industries will be detailed in lectures, while tutorial sessions will also be used to share practical information.



These complementary teaching and learning strategies will allow each student to apply what they have learned to an industrial setting, and use teamwork, problem solving and brainstorming to critically engage with the subject, actively engage in troubleshooting and propose strategies for solving problems. The students will also be required to learn from discussions with one another, and give examples in relation to their own experience in the context of their working environment.



Continuous assessment will be carried out throughout the course of the programme.

The Certificate in International Regulatory Affairs is aimed at participants who are employed within the Regulatory or Compliance functions of pharmaceutical and medtech companies, and who wish to upskill or seek employment in the regulatory departments of such organisations.



International Regulatory Affairs Entry Requirements



Applicants for entry to this programme should hold a Level 8 Bachelor’s degree at honours level minimum 2.2 in an appropriate subject area or equivalent qualification.

Applicants whose first language is not English must submit evidence of competency in English, please see

SETU’s English Language Requirements

for details.

4 Months Part Time

Start Date: October 2025

This course places a strong emphasis on the professional development of the graduate and is aimed at students already working in an industrial environment. Such a qualification will enable and facilitate career progression for graduates in the region.



This programme can be taken as a stand-alone Certificate worth 10 credits at level 9, or if the student wishes, they can use these credits towards the 60 credit Postgraduate Diploma in Analytical Science with Quality Management SE51H /SE51J or the 90 creditMSc in Analytical Science with Quality Management SE51H /SE51J