Strategic EU Regulatory Director – Oncology

AstraZeneca plc; Cambridge; Presencial; GBP 120 000 - 180 000; Tempo integral

Resumo da oferta

AstraZeneca plc in the United Kingdom seeks a Regulatory Affairs Director to shape EU regulatory strategies for oncology therapies and drive major submissions across development, submission, approval and lifecycle management. You will collaborate with scientists, clinicians and commercial teams in a global matrix to accelerate innovation and patient access.

The role entails leading engagement with EMA and national authorities, crafting strategy documents, and mentoring the Global Regulatory

Qualificações

• Bachelor's degree in Life Sciences or related field.
• 5+ years in regulatory affairs or drug development with major health authority interactions.

Responsabilidades

• Lead major regulatory submissions (MAA/CTR/IVDR/CTA) and health authority interactions.
• Develop EU/regional regulatory strategies to speed approvals and optimal labeling.
• Craft engagement plans for health authorities and coordinate briefings.
• Contribute to Global Regulatory Strategy Team and mentor GRST members.
• Deliver regulatory milestones and manage risks with GRL collaboration.
• Plan global dossier preparation and core prescribing information.
• Partner with regional teams to influence regulatory guidance.

Conhecimentos

Regulatory strategy

Cross-functional leadership

Global health authorities

EU regulatory affairs

Formação académica

Bachelor's degree in Life Sciences

Descrição da oferta de emprego

AstraZeneca plc in the United Kingdom seeks a Regulatory Affairs Director to shape EU regulatory strategies for oncology therapies and drive major submissions across development, submission, approval and lifecycle management. You will collaborate with scientists, clinicians and commercial teams in a global matrix to accelerate innovation and patient access.

The role entails leading engagement with EMA and national authorities, crafting strategy documents, and mentoring the Global Regulatory