Role: Regulatory Manager, Intelligence Services
Company: UK based CRO/ contract research organisation
Location: UK - remote
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.
The Opportunity
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
What do you need?
* 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!