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 the Regulatory Affairs Specialist Apprenticeship training programme. 

The government is refocusing investment towards young people at the start of their working lives, rather than those already in work with higher levels of prior learning and qualifications.

From 1st January 2026, only Level 7 Apprenticeships for young people aged 16-21, and under 25 for care leavers and those with an Education, Health and Care Plan (EHCP) at the start of their apprenticeship, will be eligible for government funding (those aged 22 and over will not be eligible). Find out more here.

The TOPRA Regulatory Affairs Specialist Apprenticeship programme is still available for delivery, but please contact us for further information. 

Enquire Here

 

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.

Here are five great reasons why you should apply:


1. Real-world experience and in-demand skills 

  • The apprenticeship is a work-based programme, combining practical experience and structured training, which means that you are applying what is learnt in your day-to-day work

2. Earn while you learn 

  • Apprentices are paid for the work they do, while avoiding significant student loan fees

3. Accelerated career progression 

  • The programme is equivalent to an MSc in Regulatory Affairs, which will enable you to apply for higher-level positions. If you are a TOPRA member, you will also be able to apply for Registered Scientist (RSCi) status via a shortened route

4. Expert mentorship and networking 

  • Training is delivered by experts from industry and regulatory authorities, providing you with valuable insights and diverse perspectives

5. Comprehensive and high-quality training

 

No content found

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.