Regulatory Affairs Apprentice

Introduction

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.

About 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.

What You'll Do

• 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 Outcome

To be decided upon completion of the apprenticeship.

Skills Required

• 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

Course Information

Course: Business administrator (level 3)

Level: 3

Route: Business and administration

Apprenticeship Level: Advanced

Working Arrangements

Working Week: Monday - Friday 8am - 4pm

Expected Duration: 1 Year 6 Months

Training Provider: P.T.P. TRAINING LIMITED