ohnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.
1. 포지션: Sr. RA Specialist
2. 계열사: 존슨앤드존슨 서지컬비전 (Surgical Vision)
3. 근무지: 서울시 용산구4. 근무 형태: Regular [Responsibilities]1) Ensures compliance with regulatory regulations and interpretations2) Coordinates, compiles, and submits new product applications, change applications and re-evaluation to the regulatory agencies.3) Ensures collection of all related documentation as required to obtain the approvals from agencies or in response to agency inquiries4) Prepares responses to regulatory agencies' questions and other correspondence as requested5) Assists with organizing and maintaining reporting schedules for new/change applications6) Prepares the necessary outlines, summaries, status reports, memos, tables, and slides for updates to manager and team.7) Manages specific project steps to deliver required objectives independently/or with some supervision8) Maintains and archives all regulatory documentation9) Help to maintain license database systems for Korea.10) Create Korean language label for newly registered product or revise labels for completed license amendments.11) Support project work with cross functions as needed [Requirements]- Bachelor’s degree or above is required- Major in Chemistry, Biology, Engineering preferred- Minimum 5 years of progressive experience in Regulatory Affairs- Good English Communication skill (writing & oral)- Understanding of the Korean regulatory requirements- Basic understanding of medical devices and life-cycle management based on the knowledge and comprehension of the relative laws and regulations- Utilizes strategic thinking and intellectual curiosity to find solutions- Understands business environment and business strategies, and develops effective and results-oriented regulatory strategy that are in line with business objectives [지원 방법]
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[제출 서류]영문 자유 양식의 이력서/자기소개서 [서류 마감일] 채용시 마감 [For more J&J Korea Information]링크드인 채용 페이지: https://www.linkedin.com/company/johnson-&-johnson/존슨앤드존슨 채용 및 다양한 소식들을 링크드인 채용 페이지를 ‘좋아요’ 및 ‘팔로우’ 하시고 만나보시기 바랍니다.
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