Oncology Regulatory Affairs Director — EU Strategy Lead

AstraZeneca plc; United Kingdom; On-site; GBP 120,000 - 180,000; Full time

Job summary

AstraZeneca plc is seeking a Regulatory Affairs Director to lead EU regulatory strategies and major submissions that accelerate oncology innovation and patient access globally.

You will direct cross-functional teams, manage health authority engagements with EMA and national bodies, and shape labeling strategies. Advanced expertise in IVDR, CTR, MAAs, CTAs, and lifecycle management will be pivotal in this high-profile role.

Qualifications

• Regulatory affairs and drug development expertise in pharma/biotech.
• Experience preparing major health authority interactions and briefing documents.

Responsibilities

• Lead major regulatory submissions (MAA/CTR/IVDR/CTA) and health authority interactions.
• Develop and implement regional/global regulatory strategies to accelerate approvals.
• Craft EU engagement plans, drive briefing documents and conduct meetings.
• Contribute to Global Regulatory Strategy Team and mentor GRST members.
• Deliver regulatory milestones with risk assessments and labeling coordination.
• Negotiate with health authorities and assemble global dossiers and core labeling.

Skills

Regulatory strategy

Regulatory submissions

Project leadership

Cross-functional collaboration

Strategic thinking

Education

Bachelor's degree in Life Sciences

Job description

AstraZeneca plc is seeking a Regulatory Affairs Director to lead EU regulatory strategies and major submissions that accelerate oncology innovation and patient access globally.

You will direct cross-functional teams, manage health authority engagements with EMA and national bodies, and shape labeling strategies. Advanced expertise in IVDR, CTR, MAAs, CTAs, and lifecycle management will be pivotal in this high-profile role.