" \u003cdiv class=\"ja-job-details\"\u003e \u003ch2 class=\"title\"\u003eSafety \u0026amp; Regulatory Specialist Taiwan\u003c/h2\u003e \u003cdiv class=\"meta\"\u003e \u003cul class=\"classifications\"\u003e \u003cli data-id=\"23519\"\u003e Medical \u0026amp; Scientific \u003c/li\u003e \u003cli data-id=\"23520\"\u003e Regulatory Operations \u003c/li\u003e \u003cli data-id=\"23521\"\u003e Taiwan \u003c/li\u003e \u003cli data-id=\"23522\"\u003e Permanent / Full Time \u003c/li\u003e \u003c/ul\u003e \u003cp class=\"date-posted\"\u003e 7/10/2026 \u003c/p\u003e \u003c/div\u003e \u003cdiv class=\"description\"\u003e The Regulatory Specialist will provide key support in regulatory operations for clinical trials, ensuring compliance with local and international regulations, and facilitating timely clinical trial submissions to the Taiwan Food and Drug Administration (TFDA) and Institutional Review Boards (IRBs). \u003cbr\u003e\u003cbr\u003eWorking within a Avance CRO, this role serves as a bridge between project teams, sponsors, and regulatory authorities to support the successful initiation and management of clinical trials in Taiwan.\u003cbr\u003e\u003cbr\u003e Key Responsibilities\u003cbr\u003e\u003cbr\u003e \u003cul\u003e \u003cli\u003e\u003cstrong\u003eSafety and Compliance\u003c/strong\u003e\u003c/li\u003e \u003cli\u003eOversee and support safety reporting processes in accordance with regulatory requirements and sponsor expectations.\u003c/li\u003e \u003cli\u003eEnsure all trial activities are conducted in compliance with Good Clinical Practice (GCP) and applicable regulations\u003c/li\u003e \u003cli\u003e\u0026nbsp;Ensure receipt, assessment (initial and follow up), processing and tracking of safety-related events (SAEs, EIU reports or Events of Special Interest) from study sites in accordance with the CSP, applicable regulations, SOPs, study specific SRP and any other specific agreements related to the management of safety information for a clinical trial.\u003c/li\u003e \u003cli\u003eGenerate concise and accurate case narratives liaising with the study Medical Monitor and Sponsor Medical Representative(s) as required, in accordance with each study specific SRP and Client/Avance Clinical contractual arrangements.\u003c/li\u003e \u003cli\u003eCreate, modify and/or review study specific SRPs as required per project in accordance with the CSP \u003cbr\u003eand Client/Avance Clinical contractual arrangements.\u003c/li\u003e \u003cli\u003eParticipate in Study \u0026ldquo;Kick-Off\u0026rdquo; meetings with study project staff as required.\u003c/li\u003e \u003cli\u003eAutonomously act as Lead Safety Officer and maintain oversight on regulatory compliance and status of safety-related services for assigned projects.\u003c/li\u003e \u003cli\u003eEnsure timely reporting, tracking, filing and distribution of SAE, EIU, SUSAR, and/or other safety reports (as required) to applicable parties including Regulatory Authorities (RAs), Ethics Committees (ECs), Sponsors/Clients and Investigators.\u003c/li\u003e \u003cli\u003ePerform reconciliation of SAE receipt and Regulatory reporting with Sponsors/Clients as outlined in the Study Specific SRP.\u003c/li\u003e \u003cli\u003eEnsure up-to-date knowledge of applicable regulatory safety requirements associated with relevant countries as required on a per project basis.\u003c/li\u003e \u003cli\u003eLiaise with Avance staff including the Clinical Project Managers/Directors and Study Monitors as required regarding drug safety issues at the site and for each assigned project.\u003c/li\u003e \u003cli\u003e\u003cstrong\u003ePreparation and Submission\u003c/strong\u003e\u003c/li\u003e \u003cul\u003e \u003cli\u003ePrepare, compile, and submit clinical trial application and amendment dossiers for regulatory authorities and IRBs in Taiwan (and Hong Kong when needed).\u003c/li\u003e \u003cli\u003eMaintain expert knowledge of current TFDA regulations, ICH-GCP guidelines, and corporate policies, ensuring ongoing compliance.\u003c/li\u003e \u003cli\u003eMonitor and evaluate regulatory changes, communicating updates and impacts to relevant stakeholders promptly.\u003c/li\u003e \u003cli\u003eTrack, archive, and manage all regulatory submissions to ensure a clear documentation trail.\u003c/li\u003e \u003c/ul\u003e \u003cli\u003e\u003cstrong\u003eStakeholder Communication\u003c/strong\u003e\u003c/li\u003e \u003cul\u003e \u003cli\u003eLiaise with TFDA, IRBs, and other government agencies to facilitate application evaluation, respond to information requests, and resolve regulatory queries in a timely manner.\u003c/li\u003e \u003cli\u003eCollaborate with internal teams, project managers, and external contacts (e.g., sponsors, investigators) to align on submission content and deadlines.\u003c/li\u003e \u003c/ul\u003e \u003cli\u003e\u003cstrong\u003eQuality Control and Training\u003c/strong\u003e\u003c/li\u003e \u003cul\u003e \u003cli\u003ePerform quality control (QC) checks on Trial Master File (TMF) content and regulatory submissions.\u003c/li\u003e \u003cli\u003eDeliver training and guidance on regulatory requirements and best practices to project teams as needed.\u003c/li\u003e \u003c/ul\u003e \u003c/ul\u003e \u003cstrong\u003eQualifications\u003c/strong\u003e\u003cbr\u003e \u003cul\u003e \u003cli\u003eBachelor\u0026rsquo;s degree or higher in life sciences, pharmacy, or related field.\u003c/li\u003e \u003cli\u003eMinimum of 2\u0026ndash;4 years of regulatory affairs experience in clinical research, preferably within a CRO setting in Taiwan.\u003c/li\u003e \u003cli\u003eIn-depth understanding of IND processes, ICH-GCP, TFDA, and IRB requirements for clinical trials.\u003c/li\u003e \u003cli\u003eStrong organizational, prioritization, and multi-tasking skills.\u003c/li\u003e \u003cli\u003eExcellent written and verbal communication skills in Mandarin and English.\u003c/li\u003e \u003c/ul\u003e \u003cstrong\u003eDesirable Skills\u003c/strong\u003e\u003cbr\u003e \u003cul\u003e \u003cli\u003eExperience liaising with local regulatory authorities and managing cross-functional project teams.\u003c/li\u003e \u003cli\u003eAbility to independently solve regulatory and compliance challenges.\u003c/li\u003e \u003cli\u003eFamiliarity with clinical trial management systems and regulatory tracking tools.\u003c/li\u003e \u003c/ul\u003e This position is ideal for a proactive, detail-oriented professional who thrives in a fast-paced CRO environment and is committed to ensuring compliant and efficient clinical trial operations. \u003c/div\u003e \u003cdiv class=\"apply\"\u003e \u003ca class=\"back-link\" href=\"#\" title=\"Back to search results\"\u003eBack to search results\u003c/a\u003e \u003cinput type=\"button\" class=\"ja-button\" data-job-id=\"912775\" value=\"Apply Now\" title=\"Apply Now\" /\u003e \u003c/div\u003e \u003c/div\u003e "