Regulatory and Start Up Specialist

📋 Description

• • The Regulatory and Start Up Specialist at PFM Asset Management plays a critical role in ensuring timely and compliant activation of clinical trial sites within assigned countries, directly supporting the delivery of precision medicine research in oncology and rare diseases.
• • Day-to-day responsibilities include preparing and submitting Clinical Trial Application Forms and dossiers to Competent Authorities and Ethics Committees, managing site activation timelines, coordinating document translations, maintaining regulatory intelligence and project trackers, and liaising with CRA teams and cross-functional stakeholders to ensure alignment and readiness for site activation and IMP release.
• • PFM Asset Management, part of Precision for Medicine, is a growing Clinical Research Organization dedicated to advancing precision medicine through innovative trial design, expert operational and medical teams, advanced biomarker and data analytics, and a deep commitment to rare diseases and oncology.
• • In this role, you will develop deep expertise in global clinical trial regulations, gain hands-on experience in end-to-end site start-up processes, and contribute to the successful launch of clinical studies that drive innovation in life-saving therapies.