Oncology Regulatory Affairs Director – EU Strategy Lead

AstraZeneca plc; United Kingdom; On-site; GBP 150,000 - 190,000; Full time

Job summary

AstraZeneca plc is seeking a Regulatory Affairs Director to define EU regulatory strategies for oncology medicines, accelerating innovation and global patient access. You will lead cross-functional teams through major submissions, health authority interactions, and labeling negotiations in a complex, global matrix environment.

The role demands strong leadership, strategic thinking and outstanding communication to drive regulatory milestones across development, submission, approval and lifecycle

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Biomedical Sciences or related discipline.
• +5 years' experience in regulatory affairs or drug development; including major health authority interactions.
• Experience with European regulatory pathways (IVDR, CTR, CTAs, MAAs) preferred.
• Excellent communication, strategic thinking and problem-solving.
• Ability to operate in a global matrix environment.

Responsibilities

• Lead cross-functional teams in major regulatory submissions (MAA/CTR/IVDR/CTA) and health authority interactions.
• Develop and implement regional/global regulatory strategy to deliver rapid approvals.
• Draft and negotiate briefing documents and labeling discussions with health authorities.
• Mentor GRST members and manage risks, timelines and milestones.
• Collaborate with marketing and regional regulatory staff to align on guidance.

Skills

Regulatory affairs

Regulatory strategy

Drug development

Cross-functional leadership

Communication

Strategic thinking

Education

Bachelor's degree in Life Sciences or related

Advanced degree preferred

Job description

AstraZeneca plc is seeking a Regulatory Affairs Director to define EU regulatory strategies for oncology medicines, accelerating innovation and global patient access. You will lead cross-functional teams through major submissions, health authority interactions, and labeling negotiations in a complex, global matrix environment.

The role demands strong leadership, strategic thinking and outstanding communication to drive regulatory milestones across development, submission, approval and lifecycle