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).
Working 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.
Key Responsibilities
- Safety and Compliance
- Oversee and support safety reporting processes in accordance with regulatory requirements and sponsor expectations.
- Ensure all trial activities are conducted in compliance with Good Clinical Practice (GCP) and applicable regulations
- 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.
- Generate 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.
- Create, modify and/or review study specific SRPs as required per project in accordance with the CSP and Client/Avance Clinical contractual arrangements.
- Participate in Study Kick-Off meetings with study project staff as required.
- Autonomously act as Lead Safety Officer and maintain oversight on regulatory compliance and status of safety-related services for assigned projects.
- Ensure 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.
- Perform reconciliation of SAE receipt and Regulatory reporting with Sponsors/Clients as outlined in the Study Specific SRP.
- Ensure up-to-date knowledge of applicable regulatory safety requirements associated with relevant countries as required on a per project basis.
- Liaise 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.
- Preparation and Submission
- Prepare, compile, and submit clinical trial application and amendment dossiers for regulatory authorities and IRBs in Taiwan (and Hong Kong when needed).
- Maintain expert knowledge of current TFDA regulations, ICH-GCP guidelines, and corporate policies, ensuring ongoing compliance.
- Monitor and evaluate regulatory changes, communicating updates and impacts to relevant stakeholders promptly.
- Track, archive, and manage all regulatory submissions to ensure a clear documentation trail.
- Stakeholder Communication
- Liaise with TFDA, IRBs, and other government agencies to facilitate application evaluation, respond to information requests, and resolve regulatory queries in a timely manner.
- Collaborate with internal teams, project managers, and external contacts (e.g., sponsors, investigators) to align on submission content and deadlines.
- Quality Control and Training
- Perform quality control (QC) checks on Trial Master File (TMF) content and regulatory submissions.
- Deliver training and guidance on regulatory requirements and best practices to project teams as needed.
Qualifications
- Bachelors degree or higher in life sciences, pharmacy, or related field.
- Minimum of 2-4 years of regulatory affairs experience in clinical research, preferably within a CRO setting in Taiwan.
- In-depth understanding of IND processes, ICH-GCP, TFDA, and IRB requirements for clinical trials.
- Strong organizational, prioritization, and multi-tasking skills.
- Excellent written and verbal communication skills in Mandarin and English.
Desirable Skills
- Experience liaising with local regulatory authorities and managing cross-functional project teams.
- Ability to independently solve regulatory and compliance challenges.
- Familiarity with clinical trial management systems and regulatory tracking tools.
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.
