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Lexstra Plc
Lexstra Plc
Global Regulatory Intelligence Manager - Clinical Trials/unlicensed supply management
Lexstra Plc Hounslow, London
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.
02/07/2025
Full time
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.

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