Regulatory Affairs Therapy Area Lead - Oncology

AstraZeneca

London, , GB
Regulatory strategy development
Uk regulatory compliance
Project leadership
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 equitable access to medicines, and delivering sustainable leadership prioritising health and society.
  • 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 development
  • UK regulatory compliance
  • Project leadership
  • Line management experience
  • MHRA regulatory knowledge
  • Negotiation skills

Nice-to-have

  • Therapy area expertise in oncology
  • Experience with orphan drugs
  • Clinical trial submission experience
  • Post-brexit regulatory experience
  • Flexible in-person working
  • Strong communication skills

Key Requirements

  • Life Sciences degree or professional qualifications
  • Significant UK-based pharmaceutical regulatory experience
  • Line management and project team leadership
  • Experience in commercially aware regulatory roles
  • Knowledge of MHRA requirements post Brexit

Work Rights

Not specified

Tailored Resume

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