[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]

경력사항: 경력(5년 이상 13년 이하)
학력사항: 대학교(4년)졸업

●        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

근무지: 서울 강남구 도곡동(매봉역 근방)
연봉: 경력에 따라 면접 후 상항하여 오퍼드릴 예정

문의처
그레이스앤파트너스 최지현 헤드헌터
***-****-****
shewolf@gracenpartners.com******@*******.***