This role is responsible for the end-to-end management of clinical trial regulatory submissions in Korea for new and ongoing projects
Job Summary
This role is responsible for the end-to-end management of clinical trial regulatory submissions in Korea for new and ongoing projects.
The position requires developing study-specific import licenses and representing the Regulatory Affairs function during corporate audits and agency inspections.
Candidates must collaborate with international teams, clinical project managers, and functional service providers to ensure compliance with national legal requirements.
Matching Summary
This role is responsible for the end-to-end management of clinical trial regulatory submissions in Korea for new and ongoing projects.
Skills & Requirements
Must-have
Clinical trial application management
Korea regulatory submissions experience
Import license approval execution
Regulatory inspection representation
Cross-functional team collaboration
Nice-to-have
GCP inspection response experience
Strong English communication skills
Matrix project team environment
Risk-based decision making
Functional service provider oversight
Key Requirements
Bachelor's degree in Pharmacy or health-related field
6-7 years total clinical trials experience
3-4 years regulatory submissions experience
3-4 years executing Clinical Trial Applications in Korea
In-country Functional Service Provider oversight capability