Job Description

MHRA & Regulatory Affairs Specialist / WDA(H) Application Lead (Part-Time)

Employer:

VIONIX Pharma Ltd

Contract Type:

Fixed-term (9 months) Part-time 2-3 days per week

Location:

Hybrid - UK based (remote with occasional site visits to Scotland or London)

About VIONIX Pharma

VIONIX Pharma Ltd is building next-generation digital and physical infrastructure for NHS-aligned pharmacy and pharmaceutical logistics. Backed by Innovate UK and SMART Scotland, we're creating PHARMORIS(TM), a regulatory-grade AI platform for generics optimisation and compliance automation.

The Role

This position leads our

WDA(H)

(Wholesale Dealer Authorisation - Human Use) application and MHRA regulatory-framework build-out.
You will design and document GDP / GxP-compliant quality systems, manage liaison with MHRA inspectors, and ensure our AI software and physical-pharmacy operations meet UK regulatory standards.

Key Responsibilities

Prepare and submit VIONIX Pharma's

WDA(H)

application, including GDP Quality Manual, SOP matrix, site plans and temperature-control logs. Develop and maintain MHRA-ready documentation for PHARMORIS(TM) (SaMD / AI product). Implement document control, CAPA, and deviation-tracking systems. Advise management on GxP, ISO 13485, and SaMD classification requirements. Support internal audits and pre-inspection readiness checks. Contribute to Innovate UK and SMART Scotland feasibility reports on regulatory alignment. Coordinate with external pharmacists and quality-responsible persons (QPs/RPs).

Requirements

UK resident with right to work (PAYE). Degree in Life Sciences, Pharmacy, Quality Management, or similar. 3 + years' experience in regulatory-affairs, MHRA submissions, or GDP / GxP quality systems. Demonstrable knowledge of WDA(H) processes and MHRA inspection expectations. Excellent technical writing and document-control skills. Desirable: experience with SaMD / AI / digital health regulatory pathways.

What We Offer

Flexible hybrid working (approx. 18 hours/week). Opportunity to lead a full MHRA licence application end-to-end. Direct impact on national health innovation and future compliance infrastructure. Integration with academic and industry partners across UK health-tech.
Job Type: Part-time

Pay: Up to 40,000.00 per year

Expected hours: 16 - 30 per week

Benefits:

Company events Flexitime Health & wellbeing programme Work from home
Ability to commute/relocate:

Leeds LS1 6JL: reliably commute or plan to relocate before starting work (required)
Application question(s):

How many years of experience do you have preparing or maintaining MHRA / WDA(H) documentation? Have you ever led or supported a GDP inspection? Which quality-management frameworks (GxP, ISO 13485, QMS tools) are you most familiar with? Describe a regulatory project you personally delivered -- what was the outcome? Are you open to a fixed-term, part-time role (2-3 days per week) at the stated salary band? What notice period do you have before you could start?
Work authorisation:

United Kingdom (required)
Work Location: Hybrid remote in Leeds LS1 6JL