Not Specified
Not Specified
Warwickshire
Competitive+Benefits
Fixed Term

Home
Vacancies
Regulatory Affairs Specialist

About The Role
The Regulatory Affairs Specialist will be responsible for following the instruction from Regulatory Affairs Manager and Senior Regulatory Affairs Specialists and carrying out accountabilities and tasks within all aspects of the Parallel Trade including Regulatory affairs and quality management.

They will work with Regulatory Affairs Manager and Senior Regulatory Affairs Specialists and maintain high standard of Implementation of Quality and Regulatory Strategy following the MHRA PLPI Division Legislation and MHRA Guidance.

The Role will ensure new licenses are done to the very highest standards and make them available for use by Production Teams.

This is a 12 month Maternity Cover role!

Accountabilities

Execute all new licenses and variations are submitted and implemented within a timely manner.

Execute new licenses / variations with MHRA and Quadrant License Teams

Work closely with Pharmagen and Parallel Trade Tram to ensure we can purchase and produce stocks in a timely manner.

Use the Quality Management Systems to keep the Licenses safely and accurately in line with regulatory requirements.

Ensure you keep updated with training and new procedures and processes and ensure you follow requirements.

Highlight any regulatory risks that are identified and escalate where necessary.

Process new license applications to the highest standards to ensure reduction in RFI’s from the MHRA

Provide support to Pharmagen Production and Quality Departments

Why AAH?

AAH are the leading medical supplier in the UK, we impact millions of people across thousands of UK communities. From our network of branches, we distribute lifesaving medicines twice daily to pharmacies, hospitals and GP’s. We work collectively to make a difference. We don’t believe in standing still, which is why we are investing in our future by transforming our branch network to ensure timely and safe delivery of our valued good. Our ability to shape the future of healthcare depends on the passion and hard work of our people.
25 days Plus Bank Holidays

Company Sick Pay

Pension Scheme

Long Service Awards

Death in Service

Discounted Shopping Platform

Employee Assistance Programme

Excellent Career progression with full ongoing Support

Onsite parking with excellent working conditions and transport links. (Check out the map to find our exact location).
About You
- Regulatory Affairs and Parallel Trade Experience
- In depth understanding of the pharmaceutical industry, Parallel Trade, and products within it.
- Experience of Quality Management Systems, Deviations, Change Controls, Risk Assessments, Validations and MHRA Systems
- Organised and Proactive
- Commercially aware of impact of
- Strong communicator
- Strong teamworking skills
- Flexible mindset, Creative and Problem Solver
- Good Excel skills
About Us
You will play an essential role within the AAH branch helping us to be the largest distributor of pharmaceutical and healthcare products to our customers. we impact millions of people across thousands of UK communities. From our network of branches, we distribute lifesaving medicines twice daily to pharmacies, hospitals and GP’s. We work collectively to make a difference working with our ICARE values to create a culture we can be proud of. We don’t believe in standing still, which is why we are investing in our future by transforming our branch network to ensure timely and safe delivery of our valued good.

We are an equal opportunities employer, committed to diversity & inclusion, taking a person-centred approach to our interview process that is fair and free from both discrimination and bias. If you have any reasonable adjustment needs arising from a disability or medical condition to fully participate in the recruitment process, please discuss this with our recruitment teams.