The Regulatory Affairs Specialist supports hands-on regulatory activities for assigned products in Korea, focusing on MFDS submissions, post-approval lifecycle management, and regulatory compliance
Job Summary
The Regulatory Affairs Specialist supports hands-on regulatory activities for assigned products in Korea, focusing on MFDS submissions, post-approval lifecycle management, and regulatory compliance.
Key responsibilities include preparing and filing MFDS submissions, managing regulatory change impact assessments, and reviewing promotional materials for compliance.
The role requires coordination with MFDS and global/regional regulatory teams, ensuring alignment on documentation, timelines, and follow-up actions.
Matching Summary
The Regulatory Affairs Specialist supports hands-on regulatory activities for assigned products in Korea, focusing on MFDS submissions, post-approval lifecycle management, and regulatory compliance.
Skills & Requirements
Must-have
MFDS submissions
post-approval lifecycle management
regulatory compliance activities
labeling and artwork changes
promotional materials review
Nice-to-have
detail-oriented
accountability for quality
proactive issue identification
flexibility and adaptability
clear and effective communication
Key Requirements
Bachelor’s degree in a scientific field
At least 1 year of experience in Regulatory Affairs