EU Oncology Regulatory Director – Strategy & Submissions

ASTRAZENECA UK LIMITED; Cambridge; On-site; GBP 120,000 - 170,000; Full time

Job summary

AstraZeneca UK Limited is seeking a Regulatory Affairs Director to lead EU regulatory strategies for oncology, coordinating major submissions and health authority interactions across global regions. This role emphasizes strategic leadership, cross-functional collaboration, and ensuring timely approvals for innovative medicines.

You will partner with science, medical, and commercial teams in a global matrix, guiding labeling discussions and lifecycle management while delivering regulatory

Qualifications

• 5+ years' experience in regulatory affairs, regulatory strategy, or drug development.
• Experience preparing for major health authority interactions and developing briefing documents.
• Contribution to labeling strategy and regulatory submission planning/execution.
• Experience with IVDR, CTR, CTAs, MAAs; oncology experience preferred.
• Strong communication, strategic thinking and problem-solving skills.
• Experience in a global matrix environment with cross-functional alignment.

Responsibilities

• Lead regulatory submissions and health authority interactions (EMA and national bodies).
• Develop and implement regional/global regulatory strategy to enable rapid approvals.
• Guide briefing documents and lead meetings/rehearsals for health authorities.
• Mentor GRST members and drive regulatory milestones for oncology programs.
• Own negotiations with health authorities and deliver core regulatory documents.

Skills

Regulatory strategy

Drug development

Global regulatory affairs

Leadership

Stakeholder management

Education

Bachelor's degree Life Sciences/Pharmacy/Biomedical Sciences

Job description

AstraZeneca UK Limited is seeking a Regulatory Affairs Director to lead EU regulatory strategies for oncology, coordinating major submissions and health authority interactions across global regions. This role emphasizes strategic leadership, cross-functional collaboration, and ensuring timely approvals for innovative medicines.

You will partner with science, medical, and commercial teams in a global matrix, guiding labeling discussions and lifecycle management while delivering regulatory