European Regulatory Lead, Oncology (Director)

AstraZeneca GmbH; Cambridge; On-site; GBP 180,000 - 240,000; Full time

Job summary

AstraZeneca Cambridge is seeking a Regulatory Affairs Director to shape European regulatory strategy for oncology products, driving rapid approvals and competitive labeling across Europe. You will lead high‑level interactions with EMA and other authorities, and manage MAAs and labeling negotiations, partnering with cross‑functional teams from development to post‑launch.

You will guide global regulatory strategy, advise Global Product Teams, and shape strategies for new indications and phase

Qualifications

• An advanced degree in a science field and/or other appropriate knowledge/experience.
• Solid regulatory affairs knowledge in at least one therapeutic area.
• Strategic thinking, influencing, innovation, initiative, leadership and excellent communication skills.
• Ability to think strategically and evaluate risks to regulatory activities.
• Understanding guiding principles in drug development (benefit/risk, dose selection, design).
• Ability to work strategically within a complex, high‑profile development program.
• Critical thinking on global regulatory science questions and related science/clinical components.

Responsibilities

• Own and deliver European regulatory strategy for oncology products to secure rapid approvals and competitive labeling.
• Serve as the face of AstraZeneca with the EMA and European authorities; plan meetings, lead label discussions and negotiations.
• Lead MAA and variation submissions; ensure global dossier and core prescribing information meet high standards; develop briefing documents.
• Lead Global Regulatory Strategy Team as Global Regulatory Lead or European lead within the team; provide regional guidance to global plans.
• Provide strategic regulatory advice to Global Product Teams; align with CMC, Labeling, Regulatory Affairs Managers and affiliates.
• Shape strategy for new indications, novel combinations and complex evidence approaches; support end‑of‑Phase 2 to accelerate Phase 3.
• Assess emerging data against program goals; quantify regulatory risks and keep senior leaders informed.
• Lead product maintenance activities for marketed brands; safeguard supply continuity and compliance across Europe.
• Engage with regional affiliates and trade organizations to anticipate evolving guidance.

Skills

Strategic thinking

Influencing

Leadership

Oral and written communication

Risk assessment

Strategic evaluation

Education

Advanced degree in science

Job description

AstraZeneca Cambridge is seeking a Regulatory Affairs Director to shape European regulatory strategy for oncology products, driving rapid approvals and competitive labeling across Europe. You will lead high‑level interactions with EMA and other authorities, and manage MAAs and labeling negotiations, partnering with cross‑functional teams from development to post‑launch.

You will guide global regulatory strategy, advise Global Product Teams, and shape strategies for new indications and phase