Regulatory Affairs Apprentice – C.S.T Pharma Ltd

Summary

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.

 

Work

Most of your apprenticeship is spent working. You’ll learn on the job by getting hands-on experience.

 

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

 

Where you'll work

Unit 5-7
Westgate Park Industrial Estate, Tintagel Way, Aldridge
Walsall
WS9 8ER

 

Training

Apprenticeships include time away from working for specialist training. You’ll study to gain professional knowledge and skills.

 

Training provider

P.T.P. TRAINING LIMITED

 

Training course

Business administrator (level 3)

Understanding apprenticeship levels (opens in new tab)

 

What you'll learn

Course contents

• Skilled in the use of multiple IT packages and systems relevant to the organisation in order to: write letters or emails, create proposals, perform financial processes, record and analyse data. Examples include MS Office or equivalent packages. Able to choose the most appropriate IT solution to suit the business problem. Able to update and review databases, record information and produce data analysis where required.


• Produces accurate records and documents including: emails, letters, files, payments, reports and proposals. Makes recommendations for improvements and present solutions to management. Drafts correspondence, writes reports and able to review others' work. Maintains records and files, handles confidential information in compliance with the organisation's procedures. Coaches others in the processes required to complete these tasks.


• Exercises proactivity and good judgement. Makes effective decisions based on sound reasoning and is able to deal with challenges in a mature way. Seeks advice of more experienced team members when appropriate.


• Builds and maintains positive relationships within their own team and across the organisation. Demonstrates ability to influence and challenge appropriately. Becomes a role model to peers and team members, developing coaching skills as they gain area knowledge.


• Demonstrates good communication skills, whether face-to-face, on the telephone, in writing or on digital platforms. Uses the most appropriate channels to communicate effectively. Demonstrates agility and confidence in communications, carrying authority appropriately. Understands and applies social media solutions appropriately. Answers questions from inside and outside of the organisation, representing the organisation or department.


• Completes tasks to a high standard. Demonstrates the necessary level of expertise required to complete tasks and applies themself to continuously improve their work. Is able to review processes autonomously and make suggestions for improvements. Shares administrative best-practice across the organisation e.g. coaches others to perform tasks correctly. Applies problem-solving skills to resolve challenging or complex complaints and is a key point of contact for addressing issues.


• Takes responsibility for initiating and completing tasks, manages priorities and time in order to successfully meet deadlines. Positively manages the expectations of colleagues at all levels and sets a positive example for others in the workplace. Makes suggestions for improvements to working practice, showing understanding of implications beyond the immediate environment (e.g. impact on clients, suppliers, other parts of the organisation). Manages resources e.g. equipment or facilities. Organises meetings and events, takes minutes during meetings and creates action logs as appropriate. Takes responsibility for logistics e.g. travel and accommodation.


• Uses relevant project management principles and tools to scope, plan, monitor and report. Plans required resources to successfully deliver projects. Undertakes and leads projects as and when required.

 

Training schedule

• 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 online 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

 

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

 

 

Requirements

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.

 

Skills

• IT skills


• Attention to detail


• Organisation skills


• Problem solving skills


• Administrative skills


• Logical


• Creative


• Initiative


• Patience

 

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

 

About this 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.

https://cstpharma.co.uk/ (opens in new tab)