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Informa PLC South Korea, 대한민국. 풀타임Job Description · The incumbent will act as a human resources generalist to designated business groups in Korea, provide HR action and advice on talent acquisition, manpower planning, organization design, talent development and employee relations. He or she need to work closely ...
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Gilead Sciences Korea Limited South Korea, 대한민국. 풀타임Description · Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercialises innovative medicines in areas of unmet medical need. Our heritage of science and innovation and the curiosity and passion of everyone who works here has enabl ...
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Netflix South Korea, 대한민국. 풀타임Netflix is the world's leading streaming entertainment service with 270 million paid memberships in over 190 countries enjoying TV series, documentaries and feature films across a wide variety of genres and languages. Members can play, pause and resume watching as much as they wa ...
Senior RA specialist - South Korea, 대한민국. - SUCCESSKOREA
설명
채용제목 Senior RA specialist 회사소개 미국계 글로벌 의료기기 회사 업무내용/자격요건 [담당직무]The purpose of this role is to provide regulatory expertise to ensures rapid and timely approvals for respective product lines by plans, manage preparation and documentation of all product registrations including his/her direct report's.
In addition, this role requires to interacts with regulatory agency personnel in order to expedite approval of pending registration and answers any questions on product documentation.
Key Responsibilities
Prioritize and develop strategies on product registration including KGMP certification for his/her respective product lines.
Preparing, coordinating and submitting regulatory applications to the local health authority.
Supervising his/her direct reports including administration of performance management and individual development plans.
Provides input on regulatory-related issues associated with compliance and achieving the business plan.
Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes and share the changes with internal stakeholders in a timely manner.
Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.Participate in global projects with regard to
