Regulatory affairs specialist apprenticeship




The skills gap in medicines and device regulatory affairs is leaving organisations short of staff at a time when there are more procedures to follow than ever before to get medicines and medical products to patients. TOPRA is supporting the profession to help fill this gap in several ways, including this apprenticeship.  

We have facilitated a multi-stakeholder employer group to design the apprenticeship standard and supporting tools, and TOPRA is a registered training provider.



What is the apprenticeship?

An apprenticeship is a work-based training programme designed around the needs of employers, which can lead to nationally and internationally recognised qualifications.

The apprenticeship programme takes 30 months to complete and provides masters-level training (Level 7) in regulatory affairs.  Apprentices are required to spend 20% of their time on regulatory training, with the other 80% spent on working and gaining experience. To start the apprenticeship, individuals must already have a job in an organisation that is willing to support them and can provide sufficient experience of working in regulatory affairs. 

The training is based on the Apprenticeship Standard which sets out the knowledge, skills and behaviours an apprentice needs to develop over the course of the programme. The Regulatory Affairs Specialist Standard was created by professionals working in a variety of organisations covering pharmaceuticals and medical devices.

Apprentices complete assessments at the end of the apprenticeship to ensure they have developed the knowledge, skills and behaviours that the programme has set out to impart. They will also complete assessments during the training programme to help embed their training and to monitor their progress. On receipt of their Regulatory Affairs Specialist Level 7 apprenticeship certificates, the apprentices are eligible to apply for Registered Scientist status via the shortened route.



Application deadlines

 Pathway  Entry Point  Application Deadline   Induction  Essentials Course  Overview Course
 Medicines/ATMPs  Autumn 2025   26 September 2025  24 October 2025  28 October 2025  4 November 2025
 Medical Devices  Autumn 2025  23 October 2025  21 November 2025  26 November 2025  2 June 2026




What are the benefits for employers?


1. Fill the skills gaps in your regulatory team 

  • There has never been more demand for skilled regulatory professionals and the gap between demand and supply is increasing. The apprenticeship is  your solution for this. 

2. Make the most of your apprenticeship levy budget before it ends for Level 7 in early 2026

  • Eligible organisations can draw down funding to help train their apprentices

3. Get highly engaged and motivated staff by giving them the opportunity to complete the apprenticeship

4. Fast-track the development of your staff through the most comprehensive training package available

  • Access our highly regarded training courses, developed and delivered by regulatory experts
  • Includes insights directly from regulators
  • Incredible opportunities to network with over 20 different training courses and webinars
  • Apprentices get to hear different viewpoints and understand the practicalities

5. A one-stop shop
We fulfil all elements of the required training. There is no need to find other training or supplements to the programme.


6. We support you and your apprentice through a monitoring process


7. We will guide you through all the paperwork and requirements

No content found

No content found

No content found


Meet some of our apprentices


 

Ksenia Sitara
Senior QC Officer, Analytical Services Group at Oxford Biomedica  

Meet Ksenia


 

Tracey Miller
Senior Quality Assurance Specialist at eXmoor Pharma Concepts Ltd  

MEET TRACEY

 

You can be confident in the quality of our apprenticeship training

TOPRA has been providing regulatory affairs training for more than 40 years and we have a commitment to quality that extends to all of our training, including the apprenticeship.

We’re proud to have been rated ‘Good’ in all areas by Ofsted in their 2024 inspection of our Level 7 Regulatory Affairs Specialist Apprenticeship. Click here to read the full report and see what they said about our expert teaching and professional network.

We also comply with all Education and Skills Funding Agency (ESFA)  requirements and are audited by them for compliance.

Apprenticeship programme policies

If you are an apprentice and have any concerns about any of these matters whilst at a training course, please make these known straight away to the TOPRA staff member at the course.

Terms & Conditions of training

  • Details of registered delegates and speakers (name, job title, company name, country only) will be placed on the attendee list for each course and this will be shared with all delegates, including, on occasion, representatives of sponsors and exhibitors. Delegates who do not wish to be included on this list should advise at least one week before the training course in writing to meetings@topra.org
  • On occasion, TOPRA takes photographs and videos which may be used to help promote our conferences and courses (both online and in print). By attending a course/event you are confirming that you are aware of this and have no objections to your image or voice appearing in any material issued by TOPRA after the meeting. However, if for any reason you do not wish TOPRA to use your image or voice please let us know.
  • Recording and photography by delegates is not permitted at any TOPRA courses or events.