Regulatory Affairs Apprentice
C.S.T PHARMA LTD · Walsall, WS9 8ER
Business administrator (level 3)
To support with pharmaceutical artwork, document control and administrative activities while completing an apprenticeship. The postholder will develop the technical knowledge and practical skills needed to progress within Regulatory Affairs, with particular exposure to parallel import licensing, packaging components and artwork management.
The work
- Provide day-to-day administrative support to the Regulatory Affairs team
- Assist with the preparation, amendment and maintenance of pharmaceutical artwork, including cartons, labels and patient information leaflets
- Use Adobe Illustrator and other approved software to support artwork changes, following training and controlled procedures
- Carry out proofreading and comparison checks to help ensure that artwork accurately reflects approved regulatory documentation
- Maintain regulatory trackers, databases, electronic folders and document filing systems
- Support the compilation, formatting and submission of regulatory documentation to the MHRA, where appropriate
- Assist with document control activities, including version control, naming, filing, archiving and retrieval of records
- Liaise professionally with colleagues in Quality, Production, Commercial and other departments, as well as approved external suppliers
- Follow applicable SOPs, work instructions, change controls and quality-system requirements
- Complete assigned apprenticeship learning, assessments and off-the-job training within agreed timescales
- Undertake other reasonable duties that support the Regulatory Affairs function and the postholder’s development
Training
- Business Administration Level 3 Standard
- Relevant workplace training
- Functional Skills if required
Your programme will be delivered online, with the following structure:
- 10 workshops which will be delivered on-line on a monthly basis
- During these sessions, new topics will be taught by your tutor
- Between sessions, you’ll complete self-study tasks spread throughout the week
- You will have regular meetings with your tutor on 1-2-1 basis every 6-8 weeks
The apprentice will receive structured workplace training and supervised experience in:
- Pharmaceutical artwork preparation and control
- Adobe Illustrator and approved artwork-management processes
- UK medicines regulation and the role of the MHRA
- Parallel import licensing and lifecycle maintenance
- Patient information leaflets, labels, cartons and Braille requirements
- Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and data integrity principles
- Change control, document control, deviation awareness and quality-system processes
- Professional communication, prioritisation and stakeholder management
Training provider: P.T.P. TRAINING LIMITED
What you come out with
To be decided upon completion of the apprenticeship.
What they are looking for
- IT skills
- Attention to detail
- Organisation skills
- Problem solving skills
- Administrative skills
- Logical
- Creative
- Initiative
- Patience
Qualifications
- Essential · GCSE English C/4 or above
- Essential · GCSE Mathematics C/4 or above
Things to consider
- Complete work accurately and within agreed deadlines
- Escalate uncertainties, discrepancies and potential errors promptly
- Maintain complete and traceable records in accordance with company procedures
- Demonstrate steady progress in both workplace competence and apprenticeship learning
- Behave professionally and contribute positively to the Regulatory Affairs team
The employer
Since 2002, CST Pharma have been procuring and supplying the UK pharmaceutical sector.
Fully licensed and regulated by the MHRA our aim is to provide healthcare providers across the UK with the very best products at competitive prices.
Strong relationships with leading pharmacy groups, manufacturers and the NHS ensures that we can offer an impressive range of products at more competitive prices than the traditional wholesale market.
Workplace
- Unit 5-7, Westgate Park Industrial Estate, Tintagel Way, Aldridge, Walsall, WS9 8ER