Hybrid Clinical Supply & Logistics Specialist

Regeneron Ireland; Dublin; Hybrid; EUR 46,000 - 75,000; Full time

Job summary

Regeneron Ireland is seeking a Clinical Supply Operations Specialist to support the Clinical Drug Supply & Logistics team in a hybrid work model in Dublin. You will oversee investigational product distribution, inventory planning, and regulatory documentation for multiple studies.

The role requires a BS/BA in a related field and 2+ years in Clinical Supplies or equivalent biopharma experience, with knowledge of ICH/GCP guidelines and IRT systems.

Qualifications

• BS/BA degree with internship or relevant work experience and 2+ years in Clinical Supplies or related fields.
• Understanding of ICH, GCP and regulatory guidelines.
• Experience supporting investigational product distribution and inventory processes.
• Familiarity with IRT management, alert management and UAT.

Responsibilities

• Manage investigational product supply and inventory planning activities for moderately sophisticated clinical studies across multiple therapeutic areas.
• Coordinate accountability, reconciliation, returns and destruction activities while maintaining accurate clinical supply records and documentation.
• Oversee internal system management including lot creation, batch status updates, inventory maintenance and shipment execution.
• Supervise supply risks, depot stocking levels, inventory trends and temperature excursions to support uninterrupted study conduct.
• Support Electronic Trial Master File (eTMF) activities, Expected Document List creation and regulatory‑compliant document management.
• Coordinate QA/QP release activities, pack‑and‑label reconciliation, inspection readiness efforts, IRT alert management and user acceptance testing activities.
• Support ancillary supply planning, procurement, inventory management, shipping logistics and lot management activities.

Skills

Clinical supplies

Inventory planning

Documentation management

Cross-functional collaboration

Regulatory knowledge

Education

BS/BA degree in related field

Tools

eTMF management

IRT management

QA/QC documentation systems

Job description

Regeneron Ireland is seeking a Clinical Supply Operations Specialist to support the Clinical Drug Supply & Logistics team in a hybrid work model in Dublin. You will oversee investigational product distribution, inventory planning, and regulatory documentation for multiple studies.

The role requires a BS/BA in a related field and 2+ years in Clinical Supplies or equivalent biopharma experience, with knowledge of ICH/GCP guidelines and IRT systems.