EU Oncology Regulatory Lead: Strategy & Approvals

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

Job summary

AstraZeneca Cambridge is seeking a Regulatory Affairs Director to lead EU regulatory strategies for oncology, accelerating innovation and bringing transformative therapies to patients worldwide. You will guide complex development, submission, approval and lifecycle activities in a global matrix, partnering with scientists, clinicians and commercial teams.

The role demands strategic leadership, cross-functional collaboration, and a track record of successful health authority interactions,

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Biomedical Sciences or related field.
• Experience in regulatory affairs, strategy, or drug development with major health authority interactions and submissions.
• Experience with IVDR, CTR, CTAs, MAAs and lifecycle management in oncology is preferred.
• Strong communication, strategic thinking and problem-solving in a global matrix.

Responsibilities

• Lead regulatory submissions (MAA/CTR/IVDR/CTA) and health authority interactions across European authorities.
• Develop and implement regional/global regulatory strategies to enable rapid approvals with competitive labeling.
• Craft EU engagement plans and briefing documents, lead rehearsals and meetings.
• Contribute to GRST within a global framework, mentoring team members.
• Deliver regulatory milestones, assess risks, and collaborate on labeling with GRL.
• Negotiate with health authorities and prepare regulatory core documents and dossiers.

Skills

Regulatory strategy

Global regulatory

Leadership

Stakeholder management

Communication

Education

Bachelor's degree in Life Sciences or related

Advanced degree preferred

Job description

AstraZeneca Cambridge is seeking a Regulatory Affairs Director to lead EU regulatory strategies for oncology, accelerating innovation and bringing transformative therapies to patients worldwide. You will guide complex development, submission, approval and lifecycle activities in a global matrix, partnering with scientists, clinicians and commercial teams.

The role demands strategic leadership, cross-functional collaboration, and a track record of successful health authority interactions,