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 pharmaceutical products.
Role type
Specialist Regulatory Affairs (Fixed-term contract)
Builds
Marketing Authorization applications, variations, renewals, and regulatory documentation for assigned products.
Domain
Healthcare / Pharmaceuticals / Regulatory Affairs
Required skills
Regulatory strategy, submission management, regulatory intelligence, artwork management, translation/QRD checks, stakeholder collaboration, SOP development, safety information evaluation, local regulation monitoring.
Preferred skills
1-3 years experience in Regulatory Affairs, proficiency in English, project management, problem solving.
Technologies
Artwork Management System, internal RA systems, regulatory databases (e.g., 의약품안전나라), UPSI.
Responsibilities
Prepare and submit Marketing Authorization applications; maintain authorized products via variations and renewals; manage labeling translation and artwork; monitor local regulations and regulatory intelligence; support cross-functional launch teams; establish Standard Operating Procedures.
Seniority
Specialist, individual contributor under supervision