About The Role
The Regulatory Affairs Specialist will be responsible for following instructions from the Regulatory Affairs Manager and Senior Regulatory Affairs Specialists, carrying out accountabilities and tasks within all aspects of Parallel Trade, including Regulatory Affairs and Quality Management.
They will work with the Regulatory Affairs Manager and Senior Regulatory Affairs Specialists to maintain high standards of implementing Quality and Regulatory Strategies, following MHRA PLPI Division Legislation and MHRA Guidance.
The role will ensure that new licenses are completed to the highest standards and made available for use by Production Teams.
Accountabilities
1. Execute all new licenses and variations, ensuring they are submitted and implemented in a timely manner.
2. Collaborate with MHRA and Quadrant License Teams to execute new licenses and variations.
3. Work closely with Pharmagen and Parallel Trade teams to ensure timely purchase and production of stocks.
4. Use the Quality Management Systems to keep licenses secure and accurate, in line with regulatory requirements.
5. Keep updated with training, procedures, and processes, and follow all requirements.
6. Identify and escalate any regulatory risks.
7. Process new license applications to high standards to reduce RFIs from MHRA.
8. Support Pharmagen Production and Quality Departments as needed.
Why AAH?
AAH is the leading medical supplier in the UK, impacting millions across communities. We distribute medicines twice daily to pharmacies, hospitals, and GPs. We are committed to making a difference and investing in our future through network transformation. Our success depends on passionate, hardworking 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 ongoing support
* Onsite parking with excellent working conditions and transport links
About You
* Experience in Regulatory Affairs and Parallel Trade
* Deep understanding of the pharmaceutical industry, Parallel Trade, and related products
* Experience with Quality Management Systems, Deviations, Change Controls, Risk Assessments, Validations, and MHRA Systems
* Organised and proactive
* Commercial awareness of regulatory impacts
* Strong communication skills
* Teamwork skills
* Flexible, creative, and problem-solving mindset
* Proficient in Excel
About Us
You will play an essential role within the AAH branch, helping us become the largest distributor of pharmaceutical and healthcare products in the UK. We impact millions across communities, distributing lifesaving medicines twice daily. We value our culture and are committed to diversity and inclusion. Please inform us of any reasonable adjustments needed during the recruitment process.
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