Regulatory Affairs 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

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 2 Health Authority interactions.
• Contribution to a regulatory approval including leading response team and labeling negotiations.
• Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.
• Experience in relevant therapy area across small molecules and biologics.

Why AstraZeneca:

Here you will join an agile, influential regulatory community that turns bold science into approval‑ready strategies. We collaborate across unexpected teams in the same room clinicians, statisticians, CMC, safety and commercial unleashing bold thinking that shapes development from the start. We challenge each other and engage regulators constructively to drive innovative data packages and secure the best possible labels. With advanced tools, growing automation and rich learning pathways, you can push beyond traditional regulatory thinking while knowing we value kindness alongside ambition. Your expertise will directly change the trajectory of medicines for patients who need them most.

What is next!

If you are ready to lead European regulatory strategy that moves life‑changing oncology medicines faster and further, step forward and make your impact now!

We are looking forward to your application not later than 31st July 2026

Date Posted

17-Jul-2026

Closing Date

31-Jul-2026

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.