Market Access & Regulatory Affairs Associate

Company: AURApeutics

  • Location: United Kingdom
  • Work mode: Remote
  • Seniority: Entry level
  • Employment type: Full-time
  • Posted: 2 days ago
  • Offer language: English

Job description

Help decide how a new therapy gets cleared, priced and bought.

AURApeutics is a startup built on six years of University of Oxford research. We’re developing ultrasound-activated nanoparticles that physically break apart treatment-resistant infections and biofilms, a new answer to antimicrobial resistance. We’re a lean, distributed team moving from benchtop R&D to clinical readiness over the next 12 months.

The role

You’ll work directly with our CEO to answer two questions every investor and hospital will ask: what will this cost, and how do we get it cleared?

What you'll actually do

  • Build the pricing engine: budget-impact and pricing models, from the cost of infection-related amputations and inpatient care to the value case a hospital finance team will accept.
  • Decode how hospitals buy: value analysis committees, DRG-bundled payment, and the codes that apply to products like ours.
  • Talk to the experts: structured interviews with hospital, payer and reimbursement experts, guided by the CEO at first.
  • Own the regulatory evidence: track FDA guidance and precedent, assemble and quality-check submission documents and meeting packages, and keep the record of every regulatory interaction.
  • Build the intern bench: find and onboard MSc project students, and from around month four help supervise them.

You're the one if…

  • You hold a BSc or MSc in Health Economics, Life Sciences, Pharmacology, Biomedical Engineering, Economics or a related field.
  • You can model: strong in Excel, ideally R or Python, and you like finding the assumption that breaks the model.
  • You write clearly enough to turn 60 pages of regulatory guidance into a one-page summary.
  • You've led a society, a project or a team, and you get others moving without waiting to be told.
  • You thrive in an autonomous, fully remote setup.

Bonus: HTA or health economics coursework, a regulatory affairs course (for example TOPRA), or time in consulting, a CRO, a hospital or procurement.

Why join us

  • Zero busywork, real impact: everything you build feeds an FDA conversation, a hospital pitch or an investor meeting.
  • A fast track: own two functions most people reach only after years, and manage people early.
  • Learn from the regulators: free training from the FDA (CDER SBIA webinars and courses, CDRH Learn) and NICE's introduction to health technology assessment.
  • Healthcare and wellbeing from day one: private medical, dental, optical and audiological cover, plus extended mental health support.
  • 100% remote within the UK, with zero commute.

Before you apply

This role is open to people who already have the right to work in the UK. We can't sponsor visas.

How to apply

Apply on our website: upload your CV (and a cover letter if you like), and write a summary of a recent FDA guidance document of about 300 words. You're welcome to use AI tools, as long as you review and edit the result yourself.

https://aurapeutics.com/careers/market-access-regulatory-affairs-associate?source=linkedin

AURA is an investigational product and is not approved for use in any country.

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