Regulatory Affairs Specialist — Clinical Trials

Pharmaxi LLC

Warszawa

Sur place

PLN 90 000 - 150 000

Plein temps

14 jours+

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Résumé du poste

Pharmaxi LLC in Warsaw seeks a Regulatory Affairs Specialist to support preparation and management of regulatory documentation for clinical projects. You will work with project teams and institutions involved in the clinical trial process.

The role emphasizes meticulous document handling, adherence to GCP requirements, submission support, and tracking deadlines. English suitable for project documentation and clear communication with partners is required.

Qualifications

Experience in regulatory affairs, clinical trials, or medical documentation.
Knowledge of GCP principles and basic regulatory requirements for clinical trials.
Very good work organization and accuracy in handling documents.
Ability to analyse formal requirements and monitor deadlines.
Knowledge of English sufficient to work with project documentation.

Responsabilités

Preparing, completing and verifying regulatory documentation for clinical trials.
Supporting submission processes and updates of project documentation.
Cooperating with the Project Manager, CRA, CTA, sponsors and investigational sites.
Monitoring document status, deadlines and required approvals.
Participating in the preparation of responses to questions or documentation supplements.
Ensuring documentation compliance with GCP requirements, procedures and applicable regulations.
Supporting archiving and maintaining the completeness of clinical trial documentation.