# Regulatory Affairs Specialist **Company**: Fortrea **Location**: Tokyo **Experience**: senior **Job type**: full-time **Category**: Healthcare **Industry**: Healthcare **Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Tokyo/Regulatory-submission-manager_265054?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_b4e20d70-2bc ## Description We are seeking a Regulatory Affairs Specialist to collaborate with Site Readiness stakeholders and cross-functional teams to ensure client-centric delivery in a matrix organisation. The successful candidate will provide oversight and accountability for Regulatory Authority (RA) submissions and coordinate activities related to Independent Review Board (IRB)/Ethics Committee (EC) and Third Body submissions for designated projects within Site Readiness. **Responsibilities:** - Provide oversight and accountability for RA submission planning, timeline management, and delivery in accordance with agreed-upon timelines. - Coordinate responses to RA queries and ensure that required response timelines are met. - Provide consolidated country requirements and regular status updates to the project team and client, as applicable. - Ensure that RA submission deliverables comply with applicable regulations, guidance requirements, and client requests. - Present at and attend external and internal meetings, including project core team and client meetings. - Initiate improvements to enhance the efficiency and quality of the submission work performed on assigned projects. - Coordinate with local and functional stakeholders to support IRB/EC and Third Body submission activities, as applicable. - Provide regulatory guidance and advice on regulatory issues related to RA submissions and associated start-up activities. - Evaluate the impact of clinical and regulatory changes on assigned projects. - Coordinate with local teams to support interactions with regulatory authorities, IRBs/ECs, and Third Bodies on behalf of clients. - Serve as the primary point of coordination for RA-related communications, as applicable. - Review and provide input into Start-Up project plans. - Distribute, implement, and monitor compliance with Start-Up project plans for RA submissions and support coordination activities related to IRB/EC and Third Body submissions. - Ensure RA submission deliverables are met within required timelines while maintaining awareness of Green Light (GL) approval and Ready-to-Enroll (RTE) milestones. - Support the tracking of IRB/EC and Third Body milestones and proactively identify and escalate to the Start-Up Lead any risks that may affect submission deliverables or site activation timelines. - Manage projects according to the billing guide to ensure that work is performed within budget. - Proactively engage in both quality assurance and risk management activities to ensure that assigned RA submission deliverables are met. - Contribute to the development of the group by participating in process improvement initiatives, such as developing and updating SOPs. - Mentor more junior Site Readiness team members. **Qualifications:** - Bachelor’s Degree in Life Sciences or equivalent. - Working knowledge of ICH-GCP and applicable clinical trial regulations. - Working knowledge of regulatory authority submission processes is required; familiarity with IRB/EC and Third Body submission processes is preferred. - Native-level Japanese language skills and business-level English proficiency are required. **Experience:** - Minimum 4 years of experience in Clinical Trial Start-Up, Regulatory Affairs, Clinical Operations, or Drug Development within the pharmaceutical, biotechnology, or CRO industry. - Experience managing or coordinating RA submissions is required. - Experience supporting IRB/EC submissions, site activation activities, or clinical trial start-up activities is preferred. - Experience with Japan Clinical Trial Notification (CTN) submissions, including the coordination of responses to related PMDA queries, is required. **Physical Demands/Work Environment:** - Office environment. - Some flexibility in scheduling may be required. ## Skills ### Required - ICH-GCP - regulatory authority submission processes - Japanese - English language ### Nice to have - IRB/EC submission processes - Third Body submission processes - Japan Clinical Trial Notification (CTN) submissions - investigational medicinal product (IMP) management activities --- Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Tokyo/Regulatory-submission-manager_265054?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)