Regulatory Affairs Therapy Area Lead - Oncology

AstraZeneca

London, United Kingdom
Competitive salary & benefits
Uk regulatory strategy
Clinical trial approvals
Mhra requirements
This role involves delivering and maintaining competitive licenses for the UK, driving regulatory strategy for new initiatives, and ensuring regulatory compliance for defined product and project responsibilities

Job Summary

  • This role involves delivering and maintaining competitive licenses for the UK, driving regulatory strategy for new initiatives, and ensuring regulatory compliance for defined product and project responsibilities.
  • We are looking for a Regulatory Affairs Therapy Lead to drive strategy and regulatory processes for products within the defined Therapy Areas.
  • At AstraZeneca's Biopharmaceuticals Business Unit, we are at the forefront of medical leadership across our enterprise and the healthcare ecosystem.

Matching Summary

This role involves delivering and maintaining competitive licenses for the UK, driving regulatory strategy for new initiatives, and ensuring regulatory compliance for defined product and project responsibilities.

Salary

Competitive Salary & Benefits

Skills & Requirements

Must-have

  • UK regulatory strategy
  • clinical trial approvals
  • MHRA requirements
  • Life Sciences Degree
  • pharmaceutical industry experience

Nice-to-have

  • Orphan drug applications
  • paediatric indications experience
  • injectable biologics expertise
  • medical devices experience
  • vaccines experience

Key Requirements

  • Life Sciences Degree or professional qualifications
  • UK-based Global Pharmaceutical company experience
  • Line management experience
  • Project team leadership experience
  • Commercially aware role experience
  • MHRA requirements knowledge
  • Post Brexit MHRA experience

Work Rights

Not specified

Tailored Resume

Cover Letter