Strong knowledge of korean medicinal product legislation
This position plays a key role in managing clinical trial application activities, import licenses, and regulatory agency inspections within Amgen Korea
Job Summary
This position plays a key role in managing clinical trial application activities, import licenses, and regulatory agency inspections within Amgen Korea.
The manager is responsible for defining submission strategies, compiling dossiers, and ensuring adherence to local regulations and company policies.
Candidates must effectively coordinate with cross-functional teams including International Regulatory, Clinical Project Management, and Global Study Operations.
Matching Summary
This position plays a key role in managing clinical trial application activities, import licenses, and regulatory agency inspections within Amgen Korea.
Skills & Requirements
Must-have
6-7 years clinical trials experience
3-4 years regulatory submissions experience
Strong knowledge of Korean medicinal product legislation
Experience executing Clinical Trial Applications in Korea
Ability to manage import licenses and regulatory inspections
Nice-to-have
Experience preparing for GCP Inspections
Fluency in English communication skills
Ability to work asynchronously across time zones
Experience managing Functional Service Providers
Key Requirements
Bachelor's degree in Pharmacy or health-related field
Minimum 6-7 years total clinical trials experience
At least 3-4 years specific regulatory submissions experience
In-depth knowledge of Korean clinical trial regulations