Location: Fully remote, based anywhere in ROIEmployment Type: Full-time, Client-DedicatedWe are seeking a Regulatory Study Start-Up Project Manager to join our team. In this role, you will work 100% dedicated to a leading global pharmaceutical company, playing a critical part in the successful initiation of clinical trials within ROI. As a Regulatory SSU PM, you'll be the engine behind timely and compliant regulatory submissions and approvals for clinical trials in ROI. From ethics committee interactions to ensuring local language materials and Informed Consents are submission-ready, you'll play a pivotal role in study start-up - when precision and speed matter most.What You'll Own:Local Submissions & ApprovalsFull ownership of clinical trial submissions to Ethics Committees and Regulatory AuthoritiesDevelopment of local language materials, including translated Informed ConsentsServe as the point of contact for approval-related interactionsCountry Oversight & DeliveryDrive country-level timelines and deliverables to meet protocol goalsEnsure compliance with local regulations, laws, and proceduresTrack research-related payments and oversee close-out reconciliationQuality & CollaborationPartner cross-functionally with Clinical Operations, Regulatory, Legal, Finance, and moreInterface with external vendors, IRBs/IECs, and regulatory bodiesContribute to local SOPs and process optimizationWhat You'll Bring:Strong expertise in local regulatory environments and submission processesExperience working with IRBs/IECs and Regulatory AuthoritiesSkilled in contract and budget negotiationAbility to influence internal and external stakeholders without direct authorityDetail-oriented mindset with a passion for timelines and compliance Why Join Fortrea?Be part of a global organization where innovation meets impact. At Fortrea, your local expertise powers global progress - helping bring life-changing therapies to patients around the world.If you are a motivated professional with a strong background in study start-up activities, this role offers an excellent opportunity to make a meaningful impact in clinical research while working in a flexible, fully remote environment.Learn more about our EEO & Accommodations request here.