Regulatory Affairs Intelligence Director

Cambridge, United Kingdom
2 days ago
Job Type
Permanent
Work Pattern
Full-time
Work Location
On-site
Seniority
Director
Education
Masters
Posted
26 May 2026 (2 days ago)

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 point person 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regulatory landscape by disease/scientific platform and coordinate with PIRS to gather input and provide feedback on draft guidance and policies.Proactively Conduct analysis of new drug development and regulatory approaches on e.g. novel clinical trial concepts, RWE, early regulatory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.

What is next:

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

So, what’s next?

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

Where can I find out more?

Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

Date Posted

26-May-2026

Closing Date

09-Jun-2026Our 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.

Related Jobs

View all jobs
Spotlight

Senior Director, Global Clinical Program Lead, Immunoglobulin

CSL
Spotlight

Director Biostatistics - Hematology

CSL

Associate Director, Regulatory Affairs

Recursion North Tyneside, NE29 8EP, United Kingdom
On-site

Director, Clinical Pharmacology

Recursion North Tyneside, NE29 8EP, United Kingdom
Hybrid

Director, Clinical Pharmacology

Recursion United Kingdom
Hybrid

Director, Clinical Pharmacology

Recursion London, United Kingdom
£118,300 – £136,500 pa Hybrid

Executive Director, External Strategy & Science Advocacy

GSK United States
On-site

Executive Director, External Strategy & Science Advocacy

GSK
On-site

Industry Insights

Discover insightful articles, industry insights, expert tips, and curated resources.

Where to Advertise Biotech Jobs in the UK (2026 Guide)

Where to advertise biotech jobs UK in 2026: the specialist boards, academic networks and trade channels that reach biotech R&D and bioprocessing talent. The candidate pool spans life scientists, computational biologists, regulatory specialists and biomanufacturing engineers — each with distinct professional networks and job search behaviours. General job boards reach a broad audience but lack the specificity that biotech professionals expect. Specialist platforms, academic channels and sector-specific communities each serve a different part of the market. This guide, published by BiotechnologyJobs.co.uk, covers where to advertise biotech roles in the UK in 2026, how the main platforms compare, what employers should expect to pay, and what the data says about hiring across different role types.

Biotech Jobs UK 2026: What to Expect Over the Next 3 Years

Biotech Jobs UK 2026: roles, salaries and the genomics, cell therapy and AI-driven drug discovery hiring trends shaping UK biotech careers. Biotechnology is creating jobs at a rate that few other sectors can match. New disciplines are emerging from research labs and entering commercial hiring pipelines, existing roles are fragmenting into deeper specialisms, and the technologies driving it all — from AI-assisted drug discovery to next-generation gene editing — are advancing faster than the workforce can keep pace with. For job seekers, this creates an unusual challenge. In most industries, career planning means navigating a relatively familiar landscape and identifying where your skills fit. In biotech, that landscape is being actively redrawn. The roles generating the most hiring activity in 2028 may look quite different from the ones appearing in job adverts today. That's not a reason to feel overwhelmed — it's a reason to get informed. The candidates who thrive in this market aren't always those with the longest CVs or the most letters after their name. They're the ones who understand where the sector is heading: which disciplines are gaining commercial traction, which technologies are driving employer demand, and how the definition of a "biotech job" is expanding well beyond traditional pharmaceuticals and research roles. This article breaks down what the UK biotech jobs market is likely to look like over the next three years — covering emerging job titles, the technologies reshaping hiring, the skills employers are prioritising right now, and how to position your career ahead of the curve rather than behind it.