Regulatory and Start Up Specialist

📋 Description

• • The Regulatory and Start Up Specialist role is critical to ensuring timely and compliant site activation for clinical trials, directly supporting Precision Medicine Group’s mission to advance precision medicine in oncology, rare diseases, and other therapeutic areas.
• • Day to day responsibilities include preparing and submitting Clinical Trial Application Forms and dossiers to Competent Authorities and Ethics Committees, managing site activation timelines, maintaining regulatory intelligence tools, coordinating document translations, and partnering with site CRAs to ensure alignment and secure site readiness.
• • The team operates within a growing Clinical Research Organization that integrates clinical trial design, medical expertise, biomarker analytics, and operational excellence to support groundbreaking cancer and rare disease therapies.
• • In this role, you will develop deep expertise in global regulatory requirements, site start-up processes, and cross-functional collaboration, positioning you for advancement in clinical operations, regulatory affairs, or project management within the life sciences industry.