Regulatory Affairs Director

Job Title:

Regulatory Affairs Director

Location:

Cambridge Salary Competitive Introduction to role:

Are you ready to shape European regulatory strategy that accelerates innovative oncology medicines to patients and secures the strongest possible labels? This role puts you at the heart of pivotal decisions, where your expertise turns cutting‑edge science into real-world impact across Europe.

As a senior leader in our global regulatory team, you will bring European insight to global strategy and influence how programs advance from early development to launch and beyond. You will partner closely with cross-functional colleagues to craft compelling data packages, steer high-stakes interactions with European regulators, and drive submissions that deliver timely approvals. Could you be the person who translates complex evidence into decisive regulatory outcomes for patients who cannot wait?

Accountabilities:

Own and deliver European regulatory strategy for assigned oncology products to secure rapid approvals with competitive labeling, leveraging expedited pathways and aligning with patient, market and business needs.

Serve as the face of AstraZeneca with the EMA and other European authorities; set engagement strategy, plan and moderate key meetings, lead label discussions and negotiations, and build trusted, influential relationships.

Lead MAA and variation submissions, ensuring the global dossier and core prescribing information are constructed to the highest standard; drive high-quality briefing documents and responses that address scientific and regulatory priorities.

Lead the Global Regulatory Strategy Team as Global Regulatory Lead for early-stage projects or specific indications, or serve as the European lead within the team, bringing clear regional strategy and guidance to global plans.

Provide strategic regulatory advice to Global Product Teams; partner with CMC, Labeling, Regulatory Affairs Managers and affiliates to align development, submission and post-approval activities for maximum patient and business value.

Shape strategy for new indications, novel combinations and complex evidence approaches; contribute to pivotal design choices and end-of-Phase 2 pathways to de-risk and accelerate Phase
3.Objectively assess emerging data against program aspirations; quantify regulatory risks and mitigations; keep senior leaders informed and adjust strategy to maintain approval speed and label competitiveness.

Lead product maintenance activities for marketed brands, safeguarding supply continuity and compliance across Europe.

Engage with regional affiliates and trade organizations to anticipate evolving guidance and influence emerging regulatory approaches.

Essential Skills/

Experience:

An advanced degree in a science related field and/or other appropriate knowledge/experience.

A solid knowledge of regulatory affairs within at least one therapeutic area in early and late development.

Demonstrated competencies of strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills.

The ability to think strategically and critically and evaluate risks to regulatory activities.

A good understanding of guiding principles in drug development such as benefit/risk profile, dose selection or statistical design.

Ability to work strategically within a complex, business critical and high-profile development program.

Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical components.

Desirable Skills/

Experience:

Prior experience of regulatory drug development or equivalent, and experience with major Health Authority interactions.

Prior experience with Phase 3 design including end of Phase…