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      고객지원센터

      02 - 555 - 5425

      nawchoi@naver.com

    구인

    제약/바이오전문 1등 헤드헌팅사 나우팜컨설팅

    외국계기업-RA 업무

    페이지 정보

    등록자 : 송흥용부사장 15-06-19 00:00

    기본정보

    외국계기업-RA 업무

    개발

    주임~대리

    무관

    무관

    서류전형 -> 1차면접 -> 2차면접

    상세정보

    본문

     Prepare submissions for the new product registration (GMP, DMF, Pharmaceutical Equivalence Test etc.)  Initiate, track and facilitate new product registrations and achieve on-time approvals ( from sending POF to approval)  Ensure maintenance of registered product license (Variations, Re-evaluation, Annual report etc.)  Monitor regulatory environment changes, and provide impact analysis plus action plans to ensure compliance  Assist Regulatory Affairs Manager to establish, develop and maintain close working relationships with the relevant regulatory authorities and associations  Assists Regulatory Affairs Manager for coordinating regulatory activities between Divisions/Business Units and have timely communications with BU RA, Regional RA  Timely update and regularly check global RA database, RegTrack and Sharepoint 