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 healthy people, society and planet.
We balance the expectation of being in the office while respecting individual flexibility and offer reasonable adjustments to help all candidates perform at their best.
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
MHRA regulatory knowledge
Project leadership and line management
Clinical trial approval delivery
UK regulatory compliance
Nice-to-have
Therapy area expertise in oncology
Experience with orphan drugs and paediatric indications
Negotiation and leadership skills
Flexible in-person working culture
Contributions to scientific advice meetings
Key Requirements
Life Sciences Degree or professional qualifications
Significant regulatory affairs experience in UK-based global pharma
Line management experience
Operational regulatory experience in commercial pharmaceutical roles