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 policy. In 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 portfolio in a given therapeutic area (TA) and communicate findings to key stakeholders and senior leaders within the assigned therapeutic area.

• Work closely with other Intelligence groups within the company (PIRS, GIACE, Clinical Information Science, etc) to provide the disease area/scientific platform specific Regulatory interpretation and impact.

• Serve as the central 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regulatory landscape by disease/scientific platform and coordinate with PIRS to gather input and provide feedback on draft guidance and policies. Proactively Conduct analysis of new drug development and regulatory approaches one.g.novel 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 relevant regulatory assessment documents from agencies to extract key insights in supporting Regulatory landscaping and strategy

• Perform research and analysis of relevant Regulatory hearings 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 of new technologies, including artificial intelligence, to facilitate regulatory 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 beyond—bringing 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.

Date Posted

27-Jul-2026

Closing Date

08-Aug-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.

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