Act as a subject matter expert on global regulatory frameworks for expanded access, compassionate use, and pre-approval access pathways
Maintain and update the regulatory intelligence database ensuring accuracy, compliance, and relevance
Liaise with global health authorities to obtain regulatory clarification, drafting strategic inquiries for targeted responses
Lead structured regulatory surveillance to track global regulatory changes and share timely updates with internal teams
Translate complex regulatory updates into actionable insights to support decision-making across departments
Develop and present regulatory intelligence reports and dashboards tailored for senior leadership and cross-functional teams
Manage and maintain country-level regulatory data across internal systems, ensuring clarity, consistency, and version control
Collaborate with internal stakeholders to refine regulatory processes and integrate local insights into the intelligence database
Utilize AI and digital tools to enhance regulatory intelligence capabilities and system efficiency
Support regulatory-focused client projects by delivering high-quality intelligence summaries and liaising directly with clients

Bachelor’s degree in life sciences, pharmacy, or related field; advanced regulatory qualification preferred
Previous experience in regulatory affairs or intelligence within biotech, pharma, CRO is essential
Hands-on experience with Early Access / Expanded Access / Compassionate Use / Named-Patient / Post-Trial Access programs
Strong regulatory intelligence skills, including monitoring, interpreting, and communicating global regulatory update
Confident client-facing communicator, able to explain complex regulatory concepts, manage stakeholders, and represent the business externally
Highly organised, detail-driven, and able to work independently as a proactive self-starter
Excellent written and verbal communication skills in English; additional languages are a plus
Experience with Market Access, clinical trial regulations, and digital / AI-enabled regulatory tools is desirable

Regulatory Manager, Intelligence Services

Key skills