Regulatory Affairs in (Bio)Pharmaceuticals - Professional Diploma

During this programme, you will:  

• Gain a clear understanding of what Regulatory Affairs is and why it is critical in the drug development process. 

• Learn how medicines are regulated to ensure their quality, safety, and efficacy, with a focus on EU frameworks and insights into US/global systems. 

• Build practical skills in preparing dossiers, navigating EU procedures (MRP, CP, DCP), and managing lifecycle strategies for new and established substances. 

• Hear from industry experts and regulatory authority speakers on best practices to improve approval success and accelerate timelines. 

• Develop confidence in professional skills, including networking, CV preparation, and interview techniques, supported by career workshops. 

Key information: 

• Complete part-time in one year  

• Blended delivery – online lectures and one on-campus day each semester. 

• On-campus day typically held on a Saturday and are not obligatory to attend.  

• Online classes are typically delivered on a Monday evening from 7- 9pm and are recorded. 

• Modules taught during spring and autumn semesters 

• Can be used to complete 30 credits towards Master of Professional Practice (MPP) or MSc Engineering Practice. 

You will learn through a blend of: 

• Lectures, project-based learning (PBL) workshops, and experiential learning 

• Reflective practice and supervised research 

• Regular feedback from faculty and peers through group work and assessments 

Spring Semester  

• Drug Regulation & the Agencies (BC5002) introduces the legal basis for medicine regulation in the (bio)pharmaceutical industry and teaches how to interpret legislation and engage effectively with regulatory authorities. 
   
• Regulatory Affairs Interactions in Drug Development & Product Marketing (BC5012) explores the regulatory role across drug development and marketing, covering codes of practice, fundamentals of traditional and biotech development, and key interactions with pharmacovigilance and medical information functions. 

• Key Regulatory Considerations for Clinical and Noon-Clinical Development and Operations (BC5022) provides an overview of clinical and non‑clinical development, EU clinical trial legislation and documentation, trial design fundamentals, scientific advice, and strategies for building a global regulatory plan. 

Autumn Semester  

• Regulatory Requirements for New Active Substances (BC5001) covers quality and CMC requirements, the structure and content of CTD/MAA dossiers, EU filing procedures (MRP, CP, DCP), and practical considerations for inspections in both EU and US contexts. 

• Regulatory Requirements for Established Active Substances (BC5011) focuses on regulatory strategies for generics and biosimilars, lifecycle management through variations and renewals, EU innovations and legislative reforms, and comparisons between EU and US systems. Includes career insights from industry experts and a forward‑looking session on the future of pharmaceuticals. 

• Employment Enhancement – career development (no credits) Provides career development support through sessions with HR and industry experts, focusing on integrity, negotiation, leadership, confidence building, and practical guidance on CVs and interview techniques. 

Relevant course materials - such as books and journal articles - will be available digitally via the UL Glucksman Library’s online resources. 

For more information on each module, you can search the faculty, school and module code on UL’s Book of Modules 

• Applicants should hold a bachelor’s degree (NFQ Level 8) with at least a second-class honour, grade 2 (2:2) in a related field. 

• You must also have at least 2 years’ relevant work experience.   

Other Entry Considerations: 

 
We encourage you to apply even if you don’t meet the standard entry requirements, as long as you can show that you have the knowledge, skills, and experience needed for the programme. 
 
At UL, we value all kinds of learning and support different ways to qualify through our Recognition of Prior Learning (RPL) policy.   

 
International students: 
 

• For details on country-specific qualifications visit postgraduate entry requirements for international students. 

Checklist of Documents: 

• *Academic transcripts and certificates
• UL graduates only need to provide their student ID.
• Copy of your CV
• Copy of your birth certificate or passport
• English translation of your qualifications and transcripts  

English Language: 

• English Language Competency certificate 

• For details on accepted language qualifications visit English Language Requirements 

Guidelines on Completing your Application  

• To make sure we can review your application quickly, please:
• Upload all documents. Your application can’t be reviewed until we have all the documents on the checklist. 
• Title the documents you are uploading. For example, "Personal Statement", "Undergraduate Transcript", "Postgraduate Transcript", "English Language Certificate" etc. 
• *If you are waiting to graduate, submit your application with the documents you have to date, you don’t need to have finished final exams before applying.

The fee for this programme is €6,500 per annum (EU and NE) 

Annual fees are billed by semester. Once registered, students may be eligible to apply for a monthly payment plan.  

Further information on fees and payment of fees is available from the Student Fees Office website. All fee related queries should be directed to the Student Fees Office (Phone: +353 61 213 007 or email student.fees.office@ul.ie).   

 
Funding 

Find further information on funding and scholarships..