Regulatory Affairs Therapy Area Lead - Oncology

AstraZeneca

Regulatory strategy leadership
Uk regulatory compliance
Project leadership and line management
We are looking for a Regulatory Affairs Therapy Lead to drive strategy and regulatory processes for products within the defined Therapy Areas

Job Summary

  • We are looking for a Regulatory Affairs Therapy Lead to drive strategy and regulatory processes for products within the defined Therapy Areas.
  • At AstraZeneca UK, we are committed to delivering against three missions: accelerating the UK as a global centre of excellence in life sciences, redefining healthcare through fast and equitable access to effective medicines, and delivering sustainable leadership prioritising healthy people, society and planet.
  • We balance the expectation of being in the office while respecting individual flexibility, working on average a minimum of three days per week from the office.

Matching Summary

We are looking for a Regulatory Affairs Therapy Lead to drive strategy and regulatory processes for products within the defined Therapy Areas.

Skills & Requirements

Must-have

  • Regulatory strategy leadership
  • UK regulatory compliance
  • Project leadership and line management
  • MHRA regulatory knowledge
  • Clinical trial approval delivery
  • Negotiation and leadership skills

Nice-to-have

  • Therapy area expertise in oncology
  • Experience with orphan drugs and paediatric indications
  • Experience with clinical trial submissions
  • Flexible in-person working culture
  • Contributes to scientific advice meetings

Key Requirements

  • Life Sciences Degree or professional qualifications
  • Significant UK-based pharmaceutical regulatory experience
  • Line management experience
  • Operational regulatory experience in commercial pharmaceutical roles
  • Strong knowledge of MHRA post-Brexit requirements

Work Rights

Not specified

Tailored Resume

Cover Letter