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Regulatory Affairs in (Bio) Pharmaceuticals - Specialist Diploma

Course Details

Award: Specialist Diploma
Qualification: NFQ Level 9 Minor Award Delivery:
Blended (combination of on-line and on campus delivery)
2 semesters (15 weeks each)
On-campus classes on 3 Saturdays each semester
Start Date: January 2020 Enquiries:

The Specialist Diploma in Regulatory Affairs in (Bio)Pharmaceuticals was developed with input and presentations from European Regulatory Authorities, including the Irish Health Products Regulatory Authority (HPRA), TOPRA (The Organisation for Professionals in Regulatory Affairs) as well as the European Commission. The topics and syllabus are designed to give a complete overview of the role of the Regulatory Professional in the (bio) pharmaceutical industry and will suit anybody with an interest in moving into the area of regulatory affairs who has worked in the industry or who has a suitable qualification, or for those who are currently working in the area and who wish to formalise their learning with a qualification.

The programme benefits those in the early stages of a regulatory career or seeking to transition from another function, as well as more experienced professionals seeking to enhance their knowledge or formalise their learning.

The programme runs over two semesters. Semester 1 (Jan-May) and Semester 2 (Sept.- Dec.).

The programme comprises five Taught Modules and a mandatory Career Development day. 

The Specialist Diploma in Regulatory Affairs in (Bio)Pharmaceuticals benefits those in the early stages of a regulatory career or seeking to transition from another function, as well as more experienced professionals seeking to enhance their knowledge or formalise their learning.

Applicants are normally expected to hold a relevant Level 8 primary honours degree (minimum H2.2), or an equivalent qualification, and have at least 1 year of relevant industry experience.

This Specialist Diploma is available to graduates with a background in Pharmaceutical Science, Pharmacy, Regulatory Affairs, Clinical Science/research, Medicine, Quality, Compliance, Manufacturing, Biological Sciences, Biotechnology or other science related discipline. It is designed for graduates who would like to learn about the regulation of medicines and the impact of and need for their regulation.

Alternative Entry Route
Candidates who do not meet the minimum entry criteria can be evaluated under the UL Recognised Prior Learning (RPL) policy and may be interviewed to ascertain their suitability for the programme. 

Applicants are required to meet the University of Limerick English Language requirements 

See acceptable list of English proficiency qualifications:

UL English Language Requirements

See when English Proficiency Exams can be taken in the University of Limerick:

UL English Language Test details

Semester 1 (Spring)
1. Drug Regulation and the Agencies.
2. Regulatory Affairs Interactions in Drug Development & Product Marketing.
3. Key Regulatory Considerations for Non-clinical and Clinical Development and Clinical Operations.
4. Career Development (Optional)

Semester 2 (Autumn)
1. Regulatory Requirements for a New Active Substance: Chemical and Pharmaceutical.
2. Regulatory Strategy and Requirements for Established Active Substances.

Each module (5 modules in total) has its own assessment, and this are a blend of Multiple choice questions and assignments which can be worked on in the course participants own time.

Online/distance learning with students required to attend classes three saturdays of the semester.

All employed participants must pay a contribution of the course cost directly to the provider for all level 7-9 courses. The onus is on the participant to arrange payment of this fee. The HEA will fund the remainder of the cost directly to the provider.

The Springboard+ course cost for the Specialist Diploma in Regulatory Affairs in (Bio)Pharmaceuticals for is €5,250. Employed participants will get a Springboard+ subvention of €4,725 and will have to make a contribution of €525. 

Springboard+ will pay all fees for unemployed and returner participants. 

As this is a Springboard funded Programme, initial applications will come through the Springboard website. Successful applicants will apply again through the UL system one month before course start.

Before you apply, you will need to gather documentation. Please visit the How to Apply page to read detailed guidelines on which documents to gather and the application fee. You will also find the application link for your chosen course on the 'How to Apply' page.

N.B. - We recommend that prospective students for any ULearning programmes visit the FAQ (Frequently Asked Questions) page. For any queries which are not addressed in the FAQ please do not hesitate to email or call 061 213360.