Regulatory and Start Up Specialist

📋 Description

• • The Regulatory and Start Up Specialist plays a critical role in ensuring timely and compliant site activation for clinical trials, directly supporting the advancement of precision medicine in oncology and rare diseases by managing regulatory submissions and site readiness across international jurisdictions.
• • Day-to-day responsibilities include preparing and submitting clinical trial applications to Competent Authorities and Ethics Committees, managing document translation and coordination, maintaining project trackers and regulatory intelligence tools, liaising with site CRAs and cross-functional teams, and ensuring audit/inspection readiness through proper TMF file management.
• • PFM Asset Management, part of Precision for Medicine, is a growing Clinical Research Organization dedicated to advancing innovative clinical trial designs and biomarker analytics, with a strong focus on rare diseases, oncology, and global therapeutic areas, operating with a mission-driven culture that values employee contribution and innovation.
• • In this role, the individual will develop deep expertise in global clinical trial regulations, gain hands-on experience in site start-up lifecycle management, and build cross-functional collaboration skills while contributing to the delivery of life-saving therapies, with opportunities to advance into senior regulatory or project leadership roles.