Program Overview

Regulatory Affairs in (Bio)Pharmaceuticals - Professional Diploma

Course Details

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

Brief Description

There is strong demand for skilled Regulatory Affairs professionals who can navigate complex and evolving global requirements for (bio)pharmaceuticals. This program focuses primarily on the European framework while also introducing US and international systems.

Overview

During this program, students 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.

Programme Content

• 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.

Spring Semester

• Drug Regulation & the Agencies 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 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 Non-Clinical Development and Operations 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 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 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.
• Employment Enhancement – career development 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.

Entry Requirements

• 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.
• At least 2 years' relevant work experience.
• International students: For details on country-specific qualifications, visit postgraduate entry requirements for international students.
• English Language Competency certificate

Fees

The fee for this program 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.