RA Manager
On-siteSeoul, Seoul, South Korea
Job Summary
Lead planning and execution of Clinical Trial Application (CTA) submissions in close collaboration with Clinical Operations and cross-functional stakeholders. Oversee CTA submission timelines to ensure timely, high-quality, and compliant submissions to the Health Authority, while independently preparing and managing submissions for designated new assets or priority development programs. Review and approve CTA submission packages to ensure regulatory compliance and readiness, serving as the Local Subject Matter Expert for CTA regulations by providing guidance and coaching to RA colleagues. Monitor changes in local clinical trial regulations and communicate relevant updates to stakeholders, contributing to regulatory intelligence activities and external advocacy initiatives. Support regulatory compliance and Quality Risk Management activities, including KPI tracking, audit readiness, and deviation management. Manage CTA submissions and compliance systems while interpreting audit findings to drive CAPA effectiveness.
Required Qualifications
- Minimum 9 years of experience in Regulatory Affairs
- Substantial expertise in CTA submissions
- Solid understanding of Regulatory Compliance, QMS, and/or QRM
- Ability to manage CTA submissions
- Ability to manage compliance systems
- Ability to interpret audit findings
- Ability to drive CAPA effectiveness
- Bachelor's degree (Life Science/Pharmacy)
- Strong knowledge of local and global CTA regulations and guidelines
- 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 skills
- Cross-functional collaboration skills
- Effective communication skills to engage with Health Authorities and global/regional stakeholders
Desired Qualifications
- Experience with Regulatory Compliance
- Experience with QRM
- Business Resilience
- Communication skills
- Digital Fluency
- Matrix Leadership
- Pharmaceutical Regulatory Compliance
- Stakeholder Management
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