모집분야

의약품 인허가(RA) 경력 채용 공고

📋 주요업무

Regulatory activities for new registrations, MA transfer, variations, license renewals, and lifecycle management of pharmaceutical products
Prepare, review, and submit regulatory dossiers in compliance with MFDS requirements
Serve as the primary contact for MFDS and other regulatory authorities, managing communications and regulatory inquiries
Monitor regulatory intelligence
Collaborate with cross-functional teams including local and global stakeholders to support business objectives
Ensure ongoing compliance and maintenance of product licenses throughout the product lifecycle

📋 자격요건

경력 2년 이상 ~ 5년 이하
대학교졸업(4년)이상
Bachelor's in pharmacy or equivalent in a health-related field
Work experience in product registration, variation, and MA maintenance
Good understanding of Korean pharmaceutical regulations and regulatory requirements
Experience in CTD dossier preparation, review, and submission
Ability to communicate effectively with health authorities and cross-functional stakeholders
Good written communication skills in English

📋 우대사항

Strong regulatory knowledge and experience in pharmaceutical registration and lifecycle management
Experience reviewing English documents and preparing written communications in English
Experience in regulatory affairs for imported pharmaceutical products
Experience collaborating with global, regional, or overseas stakeholders

🏠 근무조건

🎁 복지 및 혜택

🚀 채용절차

🛎️ 유의사항

클리니젠코리아(유) 의약품 인허가(RA) 경력 채용 공고