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Regulatory Submission Management (CTA Expertise) Lead planning and execution of Clinical Trial Application (CTA) submissions in close collaboration with Clinical Operations and cross-functional stakeholders. Oversee CTA submission timelines and ensure timely, high-quality, and compliant submissions to the Health Authority. Review and approve CTA submission packages prepared by RA team members to ensure regulatory compliance and submission readiness. Independently prepare and manage CTA submissions for designated new assets or priority development programs, as required. Serve as the Local Subject Matter Expert (SME) for CTA regulations and submission processes, providing regulatory guidance and coaching to RA colleagues. Support effective interactions with the MFDS throughout CTA review and approval processes. Monitor changes in local clinical trial regulations, guidelines, and regulatory policies; assess potential impacts and communicate relevant updates to local, regional, and global stakeholders. Contribute to regulatory intelligence activities by providing strategic insights on emerging regulatory trends and requirements. Participate in external advocacy and policy-shaping initiatives with regulatory authorities, industry associations, and relevant stakeholders, as appropriate. Drive continuous improvement of CTA submission processes and regulatory operational excellence. Support for Regulatory Compliance and QRM activities (as back-up, scope to be aligned) Support regulatory compliance monitoring activities and contribute to KPI tracking and reporting. Contribute to the implementation and continuous improvement of the QRM framework within LOC RA. Assist in identifying and assessing regulatory and quality risks in collaboration with relevant stakeholders. Support deviation, RCA, and CAPA management activities as part of broader compliance processes. Contribute to inspection and audit readiness activities. Collaborate with local and global stakeholders to support alignment on compliance and quality requirements.

Minimum 9 years of experience in Regulatory Affairs, with substantial expertise in CTA submissions and a solid understanding of Regulatory Compliance, QMS, and/or QRM is desirable. Required to manage CTA submissions and to manage compliance systems, interpret audit findings, and drive CAPA effectiveness​ Bachelor’s degree (Life Science/Pharmacy) Strong knowledge of local and global CTA regulations and guidelines, with hands-on experience in preparing, reviewing, and submitting CTAs to the Ministry of Food and Drug Safety (MFDS). Strong knowledge of QMS, CAPA, risk management Audit and inspection readiness experience Good understanding of regulatory requirements and product lifecycle management Strong stakeholder management, cross-functional collaboration, and effective communication skills to engage with Health Authorities and global/regional stakeholders

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