EU Regulatory Strategy Director - Oncology

AstraZeneca plc; Cambourne; On-site; GBP 120,000 - 190,000; Full time

Job summary

AstraZeneca plc is seeking a Regulatory Affairs Director to shape EU regulatory strategies for oncology medicines and drive submissions across development, approval and lifecycle management. You will lead cross-functional teams, engage with EMA and national authorities, and partner with global colleagues to deliver timely approvals and optimal labeling.

You will influence policy, mentor GRST members, and steer strategic regulatory decisions within a complex global matrix to bring transformative

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Biomedical Sciences or related field.
• Experience with major health authority interactions, briefing documents, labeling strategy, and regulatory submission planning.

Responsibilities

• Lead major regulatory submissions (MAA/CTR/IVDR/CTA) and health authority interactions (EMA and national bodies).
• Develop and implement regional/global regulatory strategies for rapid approvals and competitive labeling.
• Craft EU health authority engagement plans and briefing documents; lead meetings and rehearsals.

Skills

Regulatory strategy

Cross-functional leadership

Regulatory submissions

Stakeholder management

Strategic thinking

Education

Bachelor's degree in Life Sciences or related field

Job description

AstraZeneca plc is seeking a Regulatory Affairs Director to shape EU regulatory strategies for oncology medicines and drive submissions across development, approval and lifecycle management. You will lead cross-functional teams, engage with EMA and national authorities, and partner with global colleagues to deliver timely approvals and optimal labeling.

You will influence policy, mentor GRST members, and steer strategic regulatory decisions within a complex global matrix to bring transformative