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¿Ü±¹°èÁ¦¾à»ç RA Manager

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

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Job Requirements

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

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

¡Ü        Knowledge of regulatory agency guidelines and expectations in regulatory submission processes

¡Ü        Able to work independently and meticulously


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º¸°íü°è: Korea RA ÃÑ°ý Head ¸®Æ÷Æà ¶óÀÎ

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