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Regulatory Affairs Apprentice
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About the Role
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.
What you'll do at 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
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More training information
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
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Essential qualifications
- GCSE in:
- English (grade C/4 or above)
- Mathematics (grade C/4 or above)
Share if you have other relevant qualifications and industry experience. The apprenticeship can be adjusted to reflect what you already know.
Other requirements
- 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
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Jessica, London
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