MSc Regulatory Affairs (Medicines)


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The TOPRA MSc Regulatory Affairs (Medicines) has been running for more than 30 years. It is the go-to qualification for both established and new entrants in the profession as it is designed and delivered by expert practising regulatory professionals from a wide range of specialties and backgrounds.

Its flexibility and range are ideal for regulatory professionals who are looking for work-life balance and require a respected qualification that will support them in their career development. Its mix of theoretical, practical and strategic ensures that graduates are fully equipped to move rapidly, effectively and successfully along their desired career trajectory.

With up 22 modules (+ dissertation) available, students can tailor their programme to suit their specific needs, including the option to take up to two modules from the Medical Devices Pathway. This part-time programme allows you six years to complete the required elements.

Students may be eligible for a distinction or commendation, depending on their final results on completion of their studies, after a maximum time period of six years.

Students can opt to take a Postgraduate Certificate after completing four modules or a Postgraduate Diploma after the completion of eight modules.

Entry requirements

Entry requirements for the programme normally specify a Science degree (at the equivalent of a 2.2 or above) and that the student has obtained basic knowledge about regulatory affairs processes, documentation in the healthcare industry and has professional skills which include attention to detail, organisation and communication in an area of healthcare product development and lifecycle management.  Full entry requirements

Forms, fees and documentation

  Fees

Testimonials

Some of our graduates and module leaders talk about their experiences of the TOPRA MSc Regulatory Affairs programme.

Frequently asked questions

If you have a question about the TOPRA MSc, you may find the answer on our FAQ page. You can also contact Kay Wood, our postgraduate programmes administrator, for additional details.

Upcoming modules

Begin DateTitleDescription
04/11/2025Overview of EU and UK Pharmaceutical Regulatory AffairsThis course covers all aspects of the product development process, and provides a sound overview of EU and UK legislation and regulatory procedures, including the central role regulatory affairs plays in modern healthcare companies.IC0112025
04/11/2025Overview of EU and UK Pharmaceutical Regulatory AffairsThis course covers all aspects of the product development process, and provides a sound overview of EU and UK legislation and regulatory procedures, including the central role regulatory affairs plays in modern healthcare companies.IC21125O
10/11/2025Leadership and Strategic Management in Regulatory AffairsThis Masterclass is designed for regulatory affairs professionals to develop their understanding of the management and leadership skills needed to run a successful regulatory affairs department/organisation.  The course is designed to be applicable to both drugs and device regulatory affairs by applying the principles taught to your own particular environment. This Masterclass is also Module 10 of the MSc.MSCM1025
10/11/2025Leadership and Strategic Management in Regulatory AffairsThis Masterclass is designed for regulatory affairs professionals to develop their understanding of the management and leadership skills needed to run a successful regulatory affairs department/organisation.  The course is designed to be applicable to both drugs and device regulatory affairs by applying the principles taught to your own particular environment.MSCM1025O
02/12/2025Regulation of Electrical, Electronic and Software DevicesThis Masterclass will enable you to understand the practical and strategic regulatory issues relating to the development, maintenance and marketing of active devices. It will enable you to critically debate the commercial implications and the impaally debate the commercial implications and the impact of the regulations on product stakeholders.MDM202025
13/01/2026Data Management and Digitalisation in Regulatory AffairsGain the knowledge and practical skills to manage regulatory data in a digital world, from electronic submissions and eCompliance to regulatory information systems and IDMP implementation. This course is also Module 12 of the MSc programme.MSCM12225O
13/01/2026Data Management and Digitalisation in Regulatory AffairsGain the knowledge and practical skills to manage regulatory data in a digital world, from electronic submissions and eCompliance to regulatory information systems and IDMP implementation. This course is also Module 12 of the MSc programme.MSCM1225
27/01/2026Regulatory Environment in the Middle East and North AfricaMaster the complexities of the Middle East and North Africa's (MENA) evolving regulatory landscape and develop the insight to navigate regional challenges, drive compliance, and connect local developments to global strategies. This course is also Module 24 of the MSc programme.M240725F2F
27/01/2026Regulatory Environment in the Middle East and North AfricaMaster the complexities of the Middle East and North Africa's (MENA) evolving regulatory landscape and develop the insight to navigate regional challenges, drive compliance, and connect local developments to global strategies. This course is also Module 24 of the MSc programme.M24300725O
10/02/2026Regulatory Requirements for a New Active Substance: QualityGain the knowledge to interpret and advise on quality data requirements in pharmaceutical regulation, from manufacturing and validation to preparing CTD, IMPD and IND documentation. This Masterclass is also Module 3 of the MSc programme.MSCM32026F
10/02/2026Regulatory Requirements for a New Active Substance: QualityGain the knowledge to interpret and advise on quality data requirements in pharmaceutical regulation, from manufacturing and validation to preparing CTD, IMPD and IND documentation. This Masterclass is also Module 3 of the MSc programme.MSCM326O
24/02/2026The Regulatory Environment in South and East AsiaMaster the complexities of South and East Asia’s evolving regulatory landscape and develop strategies to support successful drug development across diverse markets. This Masterclass is also Module 25 of the MSc programme.M2525F2F
24/02/2026The Regulatory Environment in South and East AsiaMaster the complexities of South and East Asia’s evolving regulatory landscape and develop strategies to support successful drug development across diverse markets. This Masterclass is also Module 25 of the MSc programme.M2525O
24/03/2026The Regulatory Environment in the USAMaster the complexities of U.S. regulatory operations and gain the expertise to navigate FDA processes with confidence. This course is also Module 11 of the MSc programme.MSCM1126F
24/03/2026The Regulatory Environment in the USAMaster the complexities of U.S. regulatory operations and gain the expertise to navigate FDA processes with confidence. This course is also Module 11 of the MSc programme.MSCM1126O