Regulatory affairs specialist apprenticeship

The skills gap in medicines and device regulatory affairs is leaving organisations short of staff at a time when there is more to do 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.

TOPRA 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. It requires apprentices 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.

When are the application deadlines?

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

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 can be your solution for this.

2. Make the most of your apprenticeship levy budget 

• 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. No need to find other training or supplement the programme.

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

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

Who can benefit from it?

Employers based in England:  
Companies with staff based in England can use the levy to fund the training of current or new staff. Levy-paying organisations can use their levy funds and SMEs who do not pay the levy can claim 95% of the cost of the training through the digital apprenticeship service. Funds can be reserved by SMEs in advance of the apprentices training start date through the digital apprenticeship service. Contact training@topra.org to ask about the next available training start dates.

Employers outside of England:   
The apprenticeship standard and assessment plan is a useful resource to guide the training of new staff to a recognised standard. The training can be accessed by anyone, but governmental support is not available.

Eligibility

Companies – All companies whose regulatory staff are based in England (paid through a payroll address in England) can benefit from the training. You must be able to provide the apprentice with on-the-job experience of regulatory work.

Apprentices

• All apprentices must be working in England with at least 50% of their working hours spent in England.
• UK nationals must have been resident in the UK, British Overseas Territories, Channel Islands, Isle of Man or the EEA for the last three years.
• Individuals with Right of Abode in the UK must have been resident in the UK, British Overseas Territories, Channel Islands or Isle of Man for the last three years.
• Irish Nationals must have been resident in the UK, Ireland or EEA for the last three years.
• EEA citizens with pre-settled or settled status must have been resident in the EEA, Gibraltar or the UK for the last three years.
• Non-UK nationals who have the right to live and work in the UK, and who do not fit into one of the categories above, must have been resident in the UK for the last three years.

Qualifications

• Entry to the programme usually requires a science or engineering degree (at the equivalent of a 2:2 or above) and a basic knowledge about regulatory affairs processes, documentation in the healthcare industry and professional skills which include attention to detail, organisation and communication in an area of healthcare product development and lifecycle management. Candidates that do not possess the formal academic qualifications but have wide regulatory knowledge and skills may also be accepted if the candidate can demonstrate through submission of a portfolio that they are academically suited to complete the course successfully.
  
  
• In order to be eligible to complete the regulatory affairs apprenticeship with TOPRA, candidates must have one of the following English and Maths qualifications. They will not be permitted to start the apprenticeship training until evidence of these qualifications is received.
  • GCSE at grade C or above, or
  • Scottish Standard Grade Credit at level 2 or above, or
  • Scottish Higher Level at grade C or above, or
  • Have a pass for a functional skills level 2, or the equivalent.

Please contact us for details of other qualifications which are accepted.

If you are interested in joining the apprenticeship but do not currently have a regulatory role or an employer who can support you, there are a number of places where you can find opportunities:

• Apprenticeships.gov.uk
• TOPRA Jobs @ PharmiWeb.jobs
• Individual company websites
• Other regulatory recruitment sites

You can find further information about careers in regulatory affairs, graduate schemes and how to tailor your CV in TOPRA's Careers Information Pack.

Frequently Asked Questions

Download: TOPRA's Apprenticeship FAQs  

What does the training package provide?

The TOPRA apprenticeship training provides a full range of courses, starting from one-day Essentials courses which provide an overview of the regulation of medicines or medical devices through to the MSc. Over 20 different training components, including our highly-regarded Introductory courses, CRED courses, Masterclasses and webinars, are covered by the programme. 

There is also an option to study for a Postgraduate Diploma or MSc in Regulatory Affairs qualification. As these are not mandatory qualifications there are additional fees that cannot be paid for using the apprenticeship levy. These are the enrolment fee, annual registration fee or the dissertation (required for the MSc).

Where can you find out more?

You can find the apprenticeship standard and the assessment plan on the Institute for Apprenticeships and technical education website.

Download: Training plan for apprentices working in medicine regulatory affairs 

Download: Training plan for apprentices working in medical device regulatory affairs 

Apprentices working on drug-device combination products can follow either training plan and incorporate specialist training in this area.

See the dates for TOPRA's Essentials and Introductory courses, which mark the start of the apprenticeship training, on our Training Courses & Webinars list.

Contact us for the application deadlines at training@topra.org.

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.

Ofsted has responsibility for overseeing the quality of apprenticeship training. When we have been inspected by them, a report will be publicly available.

We also comply with all ESFA requirements and are audited by them for compliance.

Apprenticeship programme policies

• Complaints and Appeals Policy  
• Health and Safety Policy
• Safeguarding Policy
• Understanding Terrorism

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.

Download the handbook

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.