Senior Specialist, Regulatory Affairs(육아휴직계약직)
Core
Ensures timely regulatory approval and product license maintenance by developing registration strategies, managing submissions, and maintaining compliance with local and global standards for assigned products.
Role type
Senior Specialist, Regulatory Affairs
Builds
Marketing Authorization applications, variations, renewals, and regulatory documentation for healthcare products
Domain
Healthcare / Regulatory Affairs
Required skills
Regulatory strategy, submission management, regulatory intelligence, artwork management, translation/QRD checks, stakeholder management, SOP development, safety information evaluation, project management
Preferred skills
None stated
Technologies
Artwork Management System, internal RA systems, regulatory databases (e.g., 의약품안전나라)
Responsibilities
Prepare and submit Marketing Authorization applications; maintain authorized products via variations and renewals; manage labeling translation and artwork; monitor local regulations and provide regulatory intelligence; mentor junior team members; collaborate with cross-functional teams on product launches; participate in industry workgroups.
Seniority
Senior, hands-on IC with supervisory responsibilities