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1. Study
2. Postgraduate
3. Taught Courses
4. Masters
5. Pharmaceutical Regulatory Sciences

Course Fact File

Code	MSCPRS
Duration	12 Months
Teaching Mode	Full-time
Qualifications	MSc
NFQ Level	Level 9
Closing Date	Rolling deadline. Open until all places have been filled. Early application is advised.
Non-EU Closing Date	Open until all places have been filled or no later than 15 June. Early application is advised.
Start Date	September 2025

Course Outline

Do you have an interest in developing your career in regulatory or quality roles in the pharmaceutical or healthcare industries? Do you want to enhance your employment prospects with a new and emerging career pathway? If so our innovative new MSc Pharmaceutical Regulatory Sciences may be the right course for you!

The MSc in Pharmaceutical Regulatory Sciences at UCC has been designed to address the current and future skills demands of the pharmaceutical sector, offering a unique opportunity for graduates to fast-track their careers in the pharmaceutical industry. Graduates of this programme will gain expertise in the application of regulatory affairs within the pharmaceutical industry and develop skills in using science- and risk-based methodologies for drug development and manufacturing. This programme explores exciting and emerging topics in the pharmaceutical industry, including Advanced Therapy Medicinal Products (ATMPs) such as cell and gene therapies, digital transformation within the sector, and clinical trials. Through engaging with real-world challenges, students enhance their critical-thinking abilities and build versatile, transferable skills essential for advancing their careers in this fast-evolving and dynamic sector.

Modules

The MSc Pharmaceutical Regulatory Sciences constitutes 90 credits taken over 12 months: 60 credits of taught modules and a 30-credit dissertation in Pharmaceutical Regulatory Sciences. In addition, we facilitate a 6-month work placement during semesters 2 and 3.

Part I (60 credits), including

• PF6026 Pharmaceutical Technology & Unit Operations with Regulatory Insights (5 credits)
• PF6027 Pharmaceutical GxP & Regulatory Science (5 credits)
• PF6028 Process Control & Validation for Pharmaceutical Processes (5 credits)
• PF6029 Biotechnology-derived & Advanced Therapy Medicinal Products (ATMPs) (5 credits)
• EH6136 Pharmacoepidemiology (5 credits)
• EH6137 Pharmaceutical Data Management & Pharmacovigilance (5 credits)
• PF6032 Bioprocessing Unit Operations (5 credits)
• PF6038 Skills Development in Pharmaceutical Regulatory Sciences (10 credits)

Part II (30 credits)

• PF6031 Dissertation in Pharmaceutical Regulatory Sciences (30 credits)

Course Practicalities

The MSc in Pharmaceutical Regulatory Sciences is a full-time, 12-month programme delivered in a blended format from the date of first registration. This innovative approach combines online learning with in-person workshops, embracing a modern ‘flipped classroom’ model to enhance learning flexibility. 

Lectures, course notes, and other materials are made available on the learning platform, allowing students to engage with the content at their convenience during the week. Students will participate in on-campus workshops two days each month, scheduled on a designated Thursday and Friday. For the remaining weeks, workshops will take place online on Thursday evenings, allowing for a flexible and balanced learning experience 

Work Placement

A key feature of this MSc is the integrated 6-month industrial or research placement, providing invaluable real-world experience. This placement, undertaken during semesters 2 and 3, is hosted by industry partners or in a relevant research setting, offering students the opportunity to apply their knowledge in practice and gain hands-on experience in a professional environment. Note: For students already employed in an appropriate industrial role, this placement may be completed as part of their current employment, enabling them to apply their learning directly to their professional environment. 

Why Choose This Course

But what exactly is regulatory science?

It's the field dedicated to developing innovative tools, standards, and methods to evaluate the quality, safety, and efficacy of medicines. Given the rapid advancements in manufacturing technologies and the diverse range of medicinal products, it's imperative that our quality assessment methods remain adaptable yet rigorous, guaranteeing safe and effective treatments for patients worldwide. 

How does this regulatory science programme differ from regulatory affairs courses?

It is important to distinguish this regulatory science programme from traditional regulatory affairs courses. While regulatory affairs courses typically focus on current regulations and compliance requirements, our diploma adopts a broader, science-driven approach to drug product development and regulation. By integrating regulatory affairs with core scientific principles, this programme equips students to address challenges creatively and deliver science-based solutions to real-world industry problems. 

Who should consider applying?

This program welcomes graduates from various backgrounds, including science, health-related fields, quantitative business, and more. Whether you're looking to transition into the pharmaceutical industry or seeking to enhance your existing expertise, this MSc is tailored to meet your needs.

Placement or Study Abroad Information

This taught MSc includes an integrated industrial placement (minimum 6 months) at a placement provider within an industry or relevant research setting. The industry or research placement facilitates a real-world work experience and takes place during semesters 2 and 3 for approximately 4 days per week. 

Skills and Careers Information

Regulatory science is a crucial skill gap in Ireland, as highlighted by the Expert Group on Future Skills Needs report (2024). This program is your gateway to a dynamic career in quality and regulatory affairs. Graduates of our successful PG Diploma in Pharmaceutical Regulatory Sciences currently work in the following roles: 

• Associate Director - Clinical Regulatory Scientist 
• Director of Regulatory Affairs 
• Process Specialist 
• Senior Scientist CMC 
• Key Account Manager 
• Senior Regulatory Associate CMC 
• Senior Quality Analyst  
• Clinical Scientific Expert 
• Quality Assurance Associate 
• Research Officer 

Requirements

Applicants must have a Second Class Honours Grade 2 in a primary honours degree (NFQ, Level 8) in any of the following subject areas: chemical, biological and medical sciences, pharmacy, mathematical and computer science, engineering, public health, and business information systems.

Eligible applicants may also be invited for an interview. Selection from among eligible applicants will be made according to the following criteria:

• Performance in primary degree
• Personal statement
• Reference

Recognition of Prior Learning

Consideration under Recognition of Prior Learning (RPL) may also be given to applicants who do not meet the above entry requirements but who have relevant experience in a related field such as the chemical, biological and medical sciences, pharmaceutical industry, engineering, public health, business information systems sector, etc. To demonstrate relevant experience, applicants will be assessed on the following criteria and an interview may also be required.

• Academic achievement
• Work experience
• Personal statement
• Reference

Fees and Costs

How To Apply

The closing date for non-EU applications is Open until all places have been filled or no later than 15 June. Early application is advised.

Apply Now