Regulatory Affairs in Pharmaceuticals (Certificate, L9, 20 ECTS)

Semester 1

Regulatory Affairs (Pharmaceutical)

Provide learners with an understanding of EU regulatory systems in the pharmaceutical field.

The programme will cover the role of regulatory affairs, classification, regulatory structure, recent and forecasted changes, and the impact of various submission pathways as they apply to Pharmaceutical in the EU market. This module will explore theory, regulations, tools and techniques used in these companies. As well as giving learners competence in the appropriate legal, compliance and operational standards in industry. This module will enhance a learner’s career in regulatory affairs by developing increasing levels of competence and professionalism by obtaining a formal qualification in the pharmaceutical regulation industry.

Semester 2

Advanced Regulatory Affairs (Pharmaceutical)

Understanding of the utilisation of standards, FDA and other jurisdictions’ guidance documents and technical writing. The module will cover the role of regulatory affairs, classification, regulatory structure, recent and forecasted changes, and the impact of various submission pathways as they apply to Pharmaceutical in the world market.

(a) A minimum honours bachelor degree (Level 8) in any discipline with minimum two years, relevant work experience and/or ability, evidenced by an RPL portfolio of prior experience and learning.

or

(b) A minimum ordinary bachelor degree (Level 7) in any discipline with minimum three years relevant work experience and/or ability, evidenced by an RPL portfolio of prior experience and learning.

or

(c) Equivalent Qualifications. Applicants with equivalent qualifications on the European and International frameworks will also be considered.

or

Recognised Prior Learning (RPL) 
If you do not meet the academic entry requirements listed above but would like your application assessed under RPL please select YES on the online application form. Please include any relevant work experience/further information relevant to your application under the ‘Additional Information’ section.

English Language: Applicants who do not have English as their first language must ensure they satisfy English Language requirements. For entry to undergraduate courses, a score of 5.5 in an IELTS or equivalent exam is required. For postgraduate courses, a score of 6.0 in an IELTS or equivalent exam is required. It is the responsibility of the applicant to ensure their English proficiency meets these requirements. Please note that we do not request proof of English language qualification or proficiency.

Delivery

The programme will run for 24 Weeks, 4 hours per week

Tuesdays 7pm to 10pm

Fridays 1pm to 2pm

Start Date

There will be an online welcome session for all students on 2nd September 2026

Classes will commence on Tuesday 8th September 2026

Location

All classes will be delivered fully online

The proposed delivery schedule is subject to change.

Each 5 credits will normally equate to approximately 100 Total Learning Hours. Total Learning Hours includes the time you spend in class (lectures, tutorials, practical elements) and the time you spend completing work outside of college. The balance between these two varies by discipline, and by level of study. You should bear in mind that the workload will increase at particular times e.g. when assignments are due.

Certificate in Regulatory Affairs in Pharmaceuticals (Special Purpose Award, Level 9, 20 ECTS)

€2,800

Applications will close 2 weeks before the listed start date or once the maximum number of applicants is reached

Places are allocated on a first come first served basis

Programme run subject to viable numbers

There are multiple roles a graduate from the programme can seek in areas such as Regulatory Engineer, Quality Engineers, Regulatory Affairs Management, Process Engineering Management, Compliance and Regulatory Management, Risk Management etc.

International Opportunities offered by Programme:

The content of the modules will be seen to reflect a globalised environment .This is demonstrated by the regulatory affairs module stream which focuses on EU, US and worldwide regulatory affair bodies