Study Start Up Lead (SSUL)
On-site · Seoul, Seoul, South Korea
Job Summary
Study Start Up Lead (SSUL) specializing in IND and regulatory submissions to architect country-level start-up strategy for Roche-sponsored trials. You will optimize start-up processes by bridging global strategy with local regulatory requirements, ensure efficient and compliant trial start-up, and lead cross-functional teams. Fluency in Korean and English is required to effectively collaborate with global stakeholders. The role involves preparing IND/regulatory submissions, navigating local regulatory landscapes (MFDS/GCP), and driving improvements to speed and quality of trial initiation. Submission of resumes in Korean/English with current and desired salaries is requested; candidates will undergo a multi-stage process including document screening, interviews, and verification.
Required Qualifications
- Proven experience(5-10 years) in IND/Regulatory submissions within the pharmaceutical industry or a leading CRO
- In-depth knowledge of local regulatory requirements (MFDS, GCP, etc.) and experience interacting with HA or Ethics Committees
- A "Solution-Oriented" mindset: Ability to identify bottlenecks and proactively drive process improvements
- Strong communication skills in both Korean and English to effectively collaborate with global stakeholders
- Leadership through influence: Ability to lead cross-functional teams without formal authority
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