Junior Regulatory Affairs Specialist

5 months ago

Warwick, United Kingdom AAH Pharmaceuticals Full time

**About The Role**:
**Role**:
The Junior Regulatory Affairs Specialist will be responsible for following the instruction from Regulatory Affairs Lead and Senior Regulatory Affairs Specialist 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 Lead and Senior Regulatory 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.

**Accountabilities**:

- Executing all new licenses and variations are submitted and implemented within a timely manner.
- Executing new licenses / variations with MHRA and Quadrant License Teams
- Working closely with Pharmagen and Parallel Trade Tram to ensure we can purchase and produce stocks in a timely manner.
- Using the Quality Management Systems to keep the Licenses safely and accurately in line with regulatory requirements.
- Ensuring you keep updated with training and new procedures and processes and ensure you follow requirements.
- Highlighting any regulatory risks that are identified and escalate where necessary.
- Providing support to Pharmagen Production and Quality Departments

**Why AAH?**

AAH are the leading pharmaceutical 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. By working for AAH, you’ll have access to training and development programmes at all stages of your career through one of our many pathways; whether it’s a step into management, a regional role, or even at our Head office - the opportunities are endless.

Our ability to shape the future of healthcare depends on the passion and hard work of our people. As well as the benefits you would expect like 25 days annual leave plus bank holiday, pension scheme, company bonus scheme, we also offer:

- Market leading maternity, paternity and adoption leave
- Full support from our employee assistance programme including a health and well-being app

**About You**:
**Experience and Qualifications**:

- 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
- Experience of using data and analytical tools to support decision making.
- Analytical
- Experience of Patents and Trademark Legislation
- Experience of Specialist Software like labelling and Braile Software
- Experience of Adobe Professional
- Project Experience
- Training will be given where required

**About Us**:
Every day, millions of people rely on AAH Pharmaceuticals to deliver their medicines. We are the UK's leading wholesaler and distributor of pharmaceutical and healthcare product, serving pharmacies, hospitals and doctors nationwide. We offer services across the whole supply chain, from medicines manufacturers to delivery to the end consumer, supplying a full range of healthcare products including ethicals, generics, PIs and OTCs.

We are defined by our ICARE values and we pride ourselves on being 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 talent acquisition team.

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