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Global Regulatory Intelligence Manager - Clinical Trials/unlicensed supply management
Posted 5 hours 39 minutes ago by Lexstra Plc
Global Regulatory Intelligence Manager - Clinical Trials/unlicensed supply management
Location: Remote/Hybrid (UK-based)
Job Type: Permanent, Full-time
Regulatory Intelligence Manager with experience in regulatory affairs within Clinical Trials and/or unlicensed supply, required to join a global, compliance-driven environment focused on access to unlicensed and investigational medicines. The successful candidate will play a key role in gathering, maintaining, and interpreting critical regulatory intelligence, supporting global Managed Access and Clinical Trial programmes.
Key Responsibilities:
- Maintain and update regulatory databases and country-specific intelligence.
- Conduct in-depth research on international regulatory pathways (eg EAPs, CUPs, PA-NPPs, Clinical Trials).
- Monitor and interpret regulatory changes across key markets.
- Liaise with vendors and regulatory agencies to obtain accurate, up-to-date intelligence.
- Support strategic planning and compliance through impactful analysis and clear communication of findings.
- Present regulatory insights and risk assessments to internal stakeholders.
- Contribute to improving internal regulatory intelligence processes and tools.
Requirements:
- Extensive experience in regulatory affairs within Clinical Trials and/or unlicensed supply.
- Strong knowledge of global regulatory frameworks and legislation.
- Ability to analyse and communicate complex regulatory data effectively.
- Proficiency in Microsoft Office and regulatory tools/databases.
- Highly organised, detail-oriented, and proactive with excellent communication skills.
- Science or health-related degree preferred.
This is an excellent opportunity for a regulatory professional who is motivated by meaningful work that directly impacts patient lives. The organisation fosters a collaborative and supportive culture, where initiative and expertise are valued.
Lexstra Plc
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