Regulatory Affairs in (Bio)Pharmaceuticals - Professional Diploma

There is strong demand for skilled Regulatory Affairs professionals who can navigate complex and evolving global requirements for (bio)pharmaceuticals.   

The part-time, Level 9 Professional Diploma in Regulatory Affairs in (Bio) Pharmaceuticals develops the knowledge and practical skills needed to support safe, effective, and high‑quality medicines from development through approval and post‑market. 

Designed and delivered by experienced regulatory practitioners in UL’s Department of Chemical Sciences, the course focuses primarily on the European framework while also introducing US and international systems.  

You will learn how regulation connects with clinical, quality (CMC), pharmacovigilance, and medical information functions across the product lifecycle. 

Suitable for professionals interested in transitioning into Regulatory Affairs or enhance their current role in pharma, biotech, or related sectors. 

This programme will earn 30 ECTS credits towards a Flexible Masters Pathway, allowing students to combine Postgraduate awards to achieve a Master’s over time. 

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.