At a Glance
- Tasks: Transform regulatory intelligence into strategic advantages for faster patient access to medicines.
- Company: Join AstraZeneca, a leader in innovative healthcare solutions.
- Benefits: Competitive salary, collaborative culture, and opportunities for continuous learning.
- Other info: Work with diverse experts and embrace bold thinking in a fast-paced setting.
- Why this job: Make a real impact on drug development and patient outcomes in a dynamic environment.
- Qualifications: Advanced degree in science and strong analytical skills required.
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regulatory landscape by disease/scientific platform and coordinate with PIRS to gather input and provide feedback on draft guidance and policies.Proactively Conduct analysis of new drug development and regulatory approaches on e.g. novel clinical trial concepts, RWE, early regulatory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? Complete your application before the below closing date 8th August 2026 Salary: Negotiable
Regulatory Affairs Intelligence Director in Soham employer: AstraZeneca UK Limited
ASTRAZENECA UK LIMITED is an exceptional employer, offering a dynamic work environment at our Macclesfield campus where innovation and collaboration thrive. With a strong commitment to employee growth, we provide extensive training and development opportunities, ensuring that our team members can advance their careers while contributing to meaningful projects in the pharmaceutical industry. Our culture prioritises safety, compliance, and continuous improvement, making it a rewarding place for those passionate about making a difference in healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Intelligence Director in Soham
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If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like AstraZeneca UK Limited. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
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When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what AstraZeneca UK Limited is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Regulatory Affairs Intelligence Director in Soham
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at AstraZeneca UK Limited!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show AstraZeneca UK Limited that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at AstraZeneca UK Limited!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At AstraZeneca UK Limited, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at AstraZeneca UK Limited
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at AstraZeneca UK Limited that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with AstraZeneca UK Limited’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
