Regulatory Affairs Director

Overview

In this role you will lead European regulatory strategy for oncology products, accelerating approvals and securing strong labels. You will represent AstraZeneca with European regulators, steering high-stakes meetings and shaping global and regional plans. You will drive MAA and variation submissions, ensuring high-quality dossiers and timely approvals. You will work with cross-functional teams to align development, submission and post-approval activities, delivering patient-focused value. This is an influential, mission-driven senior role that shapes regulatory outcomes across Europe.

Responsibilities

• Own and deliver European regulatory strategy for assigned oncology products to secure rapid approvals with competitive labeling.
• Act as the face of AstraZeneca with EMA and European authorities; set engagement strategy and lead label discussions and negotiations.
• Lead MAA and variation submissions and ensure the global dossier and core prescribing information are of the highest standard.
• Lead the Global Regulatory Strategy Team as Global Regulatory Lead for early-stage projects or European lead within the team.
• Provide strategic regulatory advice to Global Product Teams and align with CMC, Labeling, and affiliates.
• Shape strategy for new indications, novel combinations and complex evidence approaches; contribute to end-of-Phase 2 designs.
• Assess emerging data against program goals, quantify regulatory risks, and inform senior leaders to maintain speed and label competitiveness.
• Lead product maintenance for marketed brands across Europe to safeguard supply and compliance.
• Engage with regional affiliates and trade organizations to anticipate evolving guidance and influence regulatory approaches.

Key requirements

• An advanced degree in a science related field or equivalent experience
• Solid knowledge of regulatory affairs in at least one therapeutic area across development stages
• Strategic thinking, influencing, leadership and excellent communication skills
• Ability to think strategically, evaluate risks, and guide regulatory activities
• Understanding of drug development principles such as benefit/risk, dose selection and statistical design
• Ability to operate strategically in complex, high-profile development programs
• Strong understanding of global regulatory science questions and related clinical components

• strategic thinking
• leadership
• excellent oral and written communication
• regulatory strategy
• MAA submissions
• EMA interactions

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