- Develop regulatory strategies aligned with the product launch plan and GRL direction.
- Prepare and submit MFDS applications in accordance with Korean regulations and GE HealthCare SOPs.
- Collaborate with GRL and internal cross-functional teams to implement bridging strategies for marketing authorization.
- Maintain product licenses by updating CMC, CCDS, and safety information as needed.
- Review promotional and external communication materials for regulatory compliance.
- Manage business licenses to support commercial operations.
Cross-functional Regulatory Support
- Provide timely and accurate regulatory insights to internal teams (Medical, Commercial, Quality, etc.).
- Participate in cross-functional projects and provide regulatory perspectives in decision-making processes.
External Collaboration & Regulatory Intelligence
- Build and maintain effective working relationships with MFDS, MoHW, and relevant industry associations.
- Monitor local regulatory changes and contribute to shaping policies aligned with GE HealthCare’s business strategy.
- Represent GE HealthCare in regulatory forums when required.
