At a Glance
- Tasks: Monitor and analyse global regulatory developments for unlicensed medicines access.
- Company: Global CRO supporting pharma and biotech in delivering life-changing medicines.
- Benefits: Remote work, collaborative culture, and impactful role in patient access.
- Other info: Opportunity for strategic influence in a dynamic international environment.
- Why this job: Join a team where your insights directly influence patient access worldwide.
- Qualifications: Degree in life sciences and experience in regulatory affairs or intelligence.
The predicted salary is between 36000 - 60000 £ per year.
Our client is a global research organisation supporting pharma and biotech partners in providing life-changing medicines to patients worldwide. With a strong international footprint and a reputation for operational excellence, they work across expanded access, compassionate use, named-patient supply, and other pre-approval access pathways.
This role sits at the heart of global early access strategy. The Regulatory Intelligence Manager will be responsible for monitoring, analysing and communicating global regulatory developments that impact access to unlicensed medicines. The position plays a critical role in maintaining a world-class regulatory intelligence database, ensuring content is accurate, current and operationally actionable. Insights generated in this role directly support compliant and timely patient access across diverse international markets.
Key Responsibilities- Act as subject matter expert on global regulatory frameworks for Expanded Access, Compassionate Use, Named-Patient and pre-approval pathways
- Lead structured global regulatory surveillance and horizon scanning activities
- Maintain and continuously improve the regulatory intelligence database, ensuring data accuracy and usability
- Liaise with global health authorities to obtain clarification on regulatory pathways, drafting targeted strategic inquiries
- Translate complex regulatory updates into clear, actionable guidance for cross-functional teams
- Develop and present intelligence reports and dashboards for senior leadership
- Manage country-level regulatory data across internal systems, ensuring consistency and version control
- Collaborate cross-functionally to integrate local insights and improve regulatory processes
- Utilise digital and AI-enabled tools to enhance intelligence capabilities
- Support client-facing regulatory intelligence projects and stakeholder interactions
- Degree in life sciences, pharmacy or related field (advanced regulatory qualification desirable)
- Proven experience in regulatory affairs or regulatory intelligence within biotech, pharma or CRO environments
- Strong hands-on exposure to Early Access / Expanded Access / Compassionate Use / Named-Patient / Post-Trial Access programmes
- Demonstrable experience monitoring, interpreting and communicating global regulatory updates
- Experience working across multiple global territories (not single-country focused)
- Confident communicator with experience engaging both internal stakeholders and external clients
- Experience with clinical trial regulations, Market Access frameworks or digital/AI-enabled regulatory systems is advantageous
This is an opportunity to join a collaborative, international organisation where regulatory intelligence directly impacts patient access and strategic decision-making. If you are looking to move into a role that combines regulatory depth, global scope and strategic influence, we would welcome a confidential discussion!
Regulatory Manager, Intelligence Services in Portsmouth employer: Fusion Group
As a leading global contract research organisation, our client offers an exceptional work environment that prioritises collaboration and innovation in the field of regulatory intelligence. Employees benefit from a remote working model that promotes work-life balance, alongside opportunities for professional growth through engagement with international markets and cutting-edge regulatory frameworks. Joining this team means contributing to meaningful projects that directly impact patient access to life-changing medicines, all while being supported by a culture of excellence and operational integrity.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Manager, Intelligence Services in Portsmouth
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of global regulatory frameworks. We recommend creating a cheat sheet of key regulations and recent updates to impress your interviewers with your expertise.
✨Tip Number 3
Showcase your skills through real-life examples. When discussing your experience, we suggest using the STAR method (Situation, Task, Action, Result) to clearly demonstrate how you’ve tackled challenges in regulatory affairs.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Regulatory Manager, Intelligence Services in Portsmouth
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the specific skills and experiences that match the Regulatory Manager role. Highlight your experience in regulatory affairs, especially in Early Access and Compassionate Use programmes, to show us you’re the right fit.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory intelligence and how your background aligns with our mission at StudySmarter. Keep it concise but impactful!
Showcase Your Communication Skills:As a Regulatory Manager, clear communication is key. In your application, demonstrate your ability to translate complex regulatory updates into actionable insights. We want to see how you can engage both internal teams and external clients effectively.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss any important updates from our team. Plus, we love seeing applications come in through our platform!
How to prepare for a job interview at Fusion Group
✨Know Your Regulatory Stuff
Make sure you brush up on global regulatory frameworks, especially around Expanded Access and Compassionate Use. Being able to discuss these topics confidently will show that you're not just familiar with the basics but are ready to dive deep into the specifics.
✨Showcase Your Analytical Skills
Prepare examples of how you've monitored and interpreted regulatory updates in the past. Think about times when your insights led to actionable changes or improvements. This will demonstrate your ability to translate complex information into clear guidance.
✨Engage with Real-World Scenarios
Be ready to discuss real-world scenarios where you liaised with health authorities or managed regulatory data. This will highlight your hands-on experience and ability to navigate the complexities of regulatory environments across different territories.
✨Communicate Clearly and Confidently
Practice articulating your thoughts clearly, especially when discussing technical subjects. Remember, you'll need to engage with both internal teams and external clients, so showcasing your communication skills is key to making a great impression.
