Regulatory affairs specialist
Level 7 · Degree (Master’s)Health and science 2.5 yr typical
About this apprenticeship
What it involves
A Regulatory Affairs Specialist ensures that pharmaceutical, medical device, or other regulated products meet the legal and scientific requirements needed to gain and maintain approval for sale in the UK and internationally. Apprentices work on regulatory submissions, liaise with agencies such as the MHRA, and advise development teams on regulatory strategy. This level 7 master's-level qualification leads to senior or principal regulatory affairs roles in the life sciences and healthcare industries.
On the job
What you’ll learn
UK and international regulatory frameworks - MHRA, EMA, FDA
Clinical trial and product development regulatory requirements
Preparing and reviewing regulatory submissions and dossiers
Post-marketing surveillance and pharmacovigilance obligations
Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP)
Regulatory strategy and risk management for product development
On the job
What you’ll do day to day
Compile and review regulatory submission documents and dossiers
Liaise with the MHRA and other regulatory agencies on applications
Advise project teams on regulatory requirements and timelines
Maintain regulatory tracking systems and document archives
Review product labelling for compliance with regulations
Monitor regulatory intelligence and assess impact of guideline changes
The deal
How this apprenticeship works
You earn a wage from day one. You are a paid employee, not a student. There are no tuition fees - the training is funded by your employer and the government.
About 20% is “off-the-job” training. Roughly a day a week is spent learning away from your normal duties - at a college, training provider, or online - working towards a recognised qualification.
It ends with an end-point assessment (EPA). Near the end, an independent assessor checks you can do the job to the national standard - through tests, a project, a portfolio or an interview. Pass it and you are fully qualified.
How to get there
What you need to start
Level 7 (Degree (Master’s)) - roughly Master’s-degree level. Usually needs a relevant degree or Level 6 qualification, or significant experience.
What’s next: Leads into senior and chartered professional roles.
Entry requirements are set by each employer and can vary - always check the specific vacancy.
Hear from employers
What it’s really like
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