[담당업무]

● Responsibility for the leadership of preparation and review of day to day regulatory submissions with full accountability for delivery
● Responsible for the maintenance activities associated with approved pharmaceutical products and/or device registrations
● Communication skills in both Korean and English to support correspondences with health authorities and cross-functional collaboration.
● Working with the global regulatory lead, regional regulatory representative to develop a regulatory strategy
● Ensuring quality of both own and teamwork and compliance with regulatory guidelines and process within required timelines
● Comprehensive knowledge and understanding on regulatory requirements applicable to pharmaceutical product registration in Korea
● PV deputy role for back up during any absence of PV responsible person
● Reporting to Head of RA/QA/PV, Korea

[자격요건]

Job Requirements

●        At least 5 years in pharmaceutical industry including three years in regulatory affairs of drug products and/or medical device

●        Good communication and interpersonal skills in both Korean and English to support correspondences with health authorities, external partners and cross-functional teams

●        Knowledge of regulatory agency guidelines and expectations in regulatory submission processes

●        Able to work independently and meticulously

회사정보: 글로벌제약사 한국법인

보고체계: Korea RA 총괄 Head 리포팅 라인

필수사항: 본사의 팀과 협업할 일이 많기 때문에 영어로 업무가 가능해야 함

근무지: 서울 강남구

연봉: 희망연봉 감안하여 상향 오퍼드릴 예정

문의처

그레이스앤파트너스 최지현이사

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