Director of Regulatory Affairs
EnergyHubSalary not specified
Full Time
Expert & Leadership (9+ years)
Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, PharmaceuticalIndustries
Requirements
- Minimum 1 year of experience in Regulatory Affairs within the pharmaceutical or healthcare industry or Health authority (MFDS etc.)
- Degree in Pharmacy or Life Sciences. Pharmacist license is preferred
- Fluent in Korean and English (both written and verbal communication)
- Solid understanding of Korean pharmaceutical regulations and regulatory procedures
- Knowledge of drug development and product lifecycle management
Responsibilities
- 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
- 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
- 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
Skills
Regulatory Affairs
MFDS Applications
Product Registration
CMC Updates
Regulatory Compliance
Korean Regulations
Cross-functional Collaboration
Regulatory Intelligence
GE Healthcare
Healthcare technology and data analytics provider
About GE Healthcare
GE Healthcare provides a range of healthcare technologies and services aimed at improving patient care. Its main products include imaging systems, mobile diagnostic devices, patient monitoring solutions, and advanced software for data analysis. These products help medical professionals make informed decisions and enhance the efficiency of healthcare delivery. Unlike many competitors, GE Healthcare invests significantly in research and development, allocating $1 billion each year to innovate and enhance its offerings. The company’s goal is to support healthcare providers in delivering better patient outcomes, as evidenced by its technology supporting over 300,000 patients daily and managing 2 billion patient scans each year.
Chicago, IllinoisHeadquarters
1892Year Founded
N/ACompany Stage
Data & Analytics, HealthcareIndustries
10,001+Employees