RA Manager

Key Responsibilities

●        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

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

본사 협업으로 영어능통자 

Korea RA 총괄 Head 리포팅 라인

Individual Contributor(일반 팀원급) 

문의: 최승진부장 shewolf@gracenpartners.com