Regulatory Affairs Intelligence Director

Job Title: Regulatory Affairs Intelligence Director

Location: Cambridge

Salary: competitive

Introduction to role:

Are you ready to turn regulatory intelligence into decisive advantage that accelerates medicines to patients This role sits at the intersection of competitive insight regulatory science and portfolio strategy translating emerging signals into clear regulatory choices for our pipeline and marketed assets.

You will partner closely with senior regulatory leaders and cross-functional intelligence groups to anticipate shifts in guidance identify precedent that unlocks smarter development pathways and shape responses that influence external an agile collaborative environment you will help convert complex data into action that shortens timelines strengthens labels and improves patient outcomes.

Accountabilities:

• Conduct analysis and impact assessment of Regulatory Intelligence across the portfolioin a giventherapeuticarea(TA)and communicate findings to key stakeholders and senior leaders withinthe assigned therapeutic area.

• Work closely with other Intelligence groups within the company (PIRS GIACE Clinical Information Scienceetc) to provide the disease area/scientific platformspecific Regulatory interpretation and impact.

• Serve asthecentral pointperson within TA in leading bespoke Regulatory research for RADs including project level Regulatory strategy due diligence disease area strategy initiatives etc.

• Partner with International China and Japan Regulatory Affairs Directors to align on TA-specific guidance and regulatory intelligence across regions; contribute to the holistic regulatory landscape by disease/scientific platform and coordinate with PIRS to gather input and provide feedback on draft guidance and Conduct analysis of new drug development and regulatory approaches clinical trial concepts RWE early regulatory access adaptive/conditional licensing as it relates to the TA

• Research and analyze Regulatory guidance precedence and other asset-specific research projects to support our products and development pipeline per market/region

• Review relevantregulatory assessment documents from agenciesto extract key insights in supporting Regulatory landscaping and strategy

• Perform research and analysis of relevantRegulatoryhearings providing pre-meeting briefings and post-meeting impact analysis to key stakeholders and senior leaders within the Company

• In coordination with functions in the TA liaise with Reg Ex/PIRS to support their development and deployment ofnew technologies including artificial intelligence tofacilitateregulatory intelligence.

Essential Skills/Experience:

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

• Demonstrate competencies of strategic thinking data and impact analysis and excellent oral and written communication skills.

• In-depth knowledge of the designated therapeutic area.

• Ability to evaluate the impact of key Regulatory Intelligence on disease area and project strategy.

• Ability to critically distinguish between noise and meaningful news to key stakeholders and senior leaders.

• Have a working knowledge about Regulatory Intelligence tools and stay current with regulatory news regarding key competitors and the disease area.

• Have a solid knowledge of US and European Regulatory Affairs.

• Have a good understanding of drug development.

Desirable Skills/Experience:

• A good understanding of the commercial aspects of drug development.

• Broad background of experience working in the pharmaceutical business and prior experience in several areas within regulatory affairs; experience in the relevant therapy area (small molecules and biologics) is preferred.

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

Why AstraZeneca:

Here regulatory intelligence directly shapes strategy from the earliest stages through approval and beyondbringing life-changing medicines to patients faster. You will work in a fast-moving collaborative setting where diverse experts come together to challenge assumptions influence external regulators on new technologies and design progressive solutions. Expect unexpected teams in the same room unleashing bold thinking backed by leaders who remove barriers and value kindness alongside ambition. With a strong focus on analytics technology adoption and continuous learning you will broaden your impact across modalities and stages of development while honing your craft through clear development paths and a culture that shares tests and improves ideas together.

What is next:

Ready to make a positive impact Apply now to join our journey towards operational excellence!

So whats next

Complete your application before the below closing date 9th June 2026

Where can I find out more

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Closing Date