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[한국얀센] Sr. Regulatory Affairs Specialist

http://careers.jnj.com

회사명	존슨앤드존슨	대표자	이정희, 김옥연

사원수	1,000명	자본금	미입력

사업내용	Consumer, Pharmaceutical, and Medical Devices

모집직종

연구/임상/개발/통계＞임상 BD/RA/QA, 연구/임상/개발/통계＞개발/RA/대관

근무지역

서울 용산구

담당업무

Regulatory Affairs

모집인원

○명

근무형태

계약직

급여사항

추후협의

자격요건

성별	무관	나이	무관
학력	대학(4년) 졸업↑	경력	3년↑

상세모집내용

<p nanum="" barun="" gothic",="" 돋움,="" dotum;="" font-size:="" 13px;="" letter-spacing:="" normal;="" background-color:="" rgb(255,="" 255,="" 255);"="" style="font-family: Arial, verdana, 돋움; letter-spacing: normal; color: rgb(51, 51, 51); margin-bottom: 5px; box-sizing: border-box;">Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.     - 계열사: 한국얀센 (Janssen) - 포지션: Sr. Regulatory Affairs Specialist - 근무지: 서울시 용산구 - 근무형태: 계약직 (Fixed term)   [Responsibilities] <ol nanum="" barun="" gothic",="" 돋움,="" dotum;="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" 255);"="" style="box-sizing: border-box; margin-top: 0px; margin-bottom: 10px; color: rgb(51, 51, 51);"><li style="box-sizing: border-box;">New product registration</li></ol><ul nanum="" barun="" gothic",="" 돋움,="" dotum;="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" 255);"="" style="box-sizing: border-box; margin-top: 0px; margin-bottom: 10px; color: rgb(51, 51, 51);"><li style="box-sizing: border-box;">Communicating with regional RA to get the dossier in a timely manner</li><li style="box-sizing: border-box;">Reviewing the dossier and submitting to MFDS with product information reflecting opinions from other departments</li><li style="box-sizing: border-box;">Timely submission of supplemental documents requested by MFDS, if any</li></ul><p nanum="" barun="" gothic",="" 돋움,="" dotum;="" font-size:="" 13px;="" letter-spacing:="" normal;="" background-color:="" rgb(255,="" 255,="" 255);"="" style="font-family: Arial, verdana, 돋움; letter-spacing: normal; color: rgb(51, 51, 51); margin-bottom: 5px; box-sizing: border-box;">2. CMC variations of approved products <ul nanum="" barun="" gothic",="" 돋움,="" dotum;="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" 255);"="" style="box-sizing: border-box; margin-top: 0px; margin-bottom: 10px; color: rgb(51, 51, 51);"><li style="box-sizing: border-box;">Reviewing the dossier and submitting to MFDS in line with Q&C</li><li style="box-sizing: border-box;">Timely submission of supplemental documents requested by MFDS, if any</li></ul><ol nanum="" barun="" gothic",="" 돋움,="" dotum;="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" 255);"="" style="box-sizing: border-box; margin-top: 0px; margin-bottom: 10px; color: rgb(51, 51, 51);"><li style="box-sizing: border-box;">Label updates</li></ol><ul nanum="" barun="" gothic",="" 돋움,="" dotum;="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" 255);"="" style="box-sizing: border-box; margin-top: 0px; margin-bottom: 10px; color: rgb(51, 51, 51);"><li style="box-sizing: border-box;">Reviewing the documents forwarded from regional RA and submitting to MFDS</li><li style="box-sizing: border-box;">Timely notification of label changes in accordance with appropriate SOP</li></ul><ol nanum="" barun="" gothic",="" 돋움,="" dotum;="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" 255);"="" style="box-sizing: border-box; margin-top: 0px; margin-bottom: 10px; color: rgb(51, 51, 51);"><li style="box-sizing: border-box;">Clinical trial application to MFDS</li></ol><ul nanum="" barun="" gothic",="" 돋움,="" dotum;="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" 255);"="" style="box-sizing: border-box; margin-top: 0px; margin-bottom: 10px; color: rgb(51, 51, 51);"><li style="box-sizing: border-box;">Communicating with GCO and regional RA to get the dossier in a timely manner</li><li style="box-sizing: border-box;">Reviewing the dossier and submitting to MFDS</li><li style="box-sizing: border-box;">Timely submission of supplemental documents requested by MFDS, if any</li></ul><ol nanum="" barun="" gothic",="" 돋움,="" dotum;="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" 255);"="" style="box-sizing: border-box; margin-top: 0px; margin-bottom: 10px; color: rgb(51, 51, 51);"><li style="box-sizing: border-box;">Review of promotional materials</li></ol><ul nanum="" barun="" gothic",="" 돋움,="" dotum;="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" 255);"="" style="box-sizing: border-box; margin-top: 0px; margin-bottom: 10px; color: rgb(51, 51, 51);"><li style="box-sizing: border-box;">Reviewing promotional materials developed by marketing PM and approval in accordance with appropriate SOP</li><li style="box-sizing: border-box;">Management of promotional materials with out of date product information</li></ul><ol nanum="" barun="" gothic",="" 돋움,="" dotum;="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" 255);"="" style="box-sizing: border-box; margin-top: 0px; margin-bottom: 10px; color: rgb(51, 51, 51);"><li style="box-sizing: border-box;">Support the regulatory activities in license management, if any.</li></ol><ul nanum="" barun="" gothic",="" 돋움,="" dotum;="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" 255);"="" style="box-sizing: border-box; margin-top: 0px; margin-bottom: 10px; color: rgb(51, 51, 51);"><li style="box-sizing: border-box;">Assist in SOP development and review.</li><li style="box-sizing: border-box;">Provide regulatory input to product lifecycle planning.</li></ul><p nanum="" barun="" gothic",="" 돋움,="" dotum;="" font-size:="" 13px;="" letter-spacing:="" normal;="" background-color:="" rgb(255,="" 255,="" 255);"="" style="font-family: Arial, verdana, 돋움; letter-spacing: normal; color: rgb(51, 51, 51); margin-bottom: 5px; box-sizing: border-box;">  [Requirements] <ol nanum="" barun="" gothic",="" 돋움,="" dotum;="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" 255);"="" style="box-sizing: border-box; margin-top: 0px; margin-bottom: 10px; color: rgb(51, 51, 51);"><li style="box-sizing: border-box;">a Bachelor or higher degree in pharmacy, or equivalent training as a healthcare provider</li><li style="box-sizing: border-box;">Minimum 3 years of experience on the pharmaceutical industry or medical environment</li><li style="box-sizing: border-box;">Sound knowledge of general medicine or pharmacy and clinical practice</li><li style="box-sizing: border-box;">Knowledge of local regulatory requirements/guidelines and global standards</li><li style="box-sizing: border-box;">Fluency in written and spoken English in addition to local language</li><li style="box-sizing: border-box;">Awareness and familiarity with industry principles of drug development and pharmacology</li><li style="box-sizing: border-box;">Proficiency in Global and Local SOPs</li><li style="box-sizing: border-box;">Good interpersonal communication skills</li><li style="box-sizing: border-box;">Ability to negotiate and communicate with internal and external customers</li></ol><p nanum="" barun="" gothic",="" 돋움,="" dotum;="" font-size:="" 13px;="" letter-spacing:="" normal;="" background-color:="" rgb(255,="" 255,="" 255);"="" style="font-family: Arial, verdana, 돋움; letter-spacing: normal; color: rgb(51, 51, 51); margin-bottom: 5px; box-sizing: border-box;">      [지원 방법] www.careers.jnj.com 접속 -> Position Number 2105911335W 검색 -> 해당 모집 공고의 “Apply Now” 클릭 후 온라인 지원 프로세스 진행   [제출 서류] 영문 자유 양식의 이력서/자기소개서 [서류 마감일] 채용시 마감   [For more Johnson & Johnson] - J&J Korea Facebook: <a href="https://www.facebook.com/JNJCareersKorea/" target="_blank" rel="noreferrer noopener" style="font-family: Arial, verdana, 돋움; color: rgb(0, 0, 0); box-sizing: border-box;">https://www.facebook.com/JNJCareersKorea/</a> - J&J Linkedin: <a href="https://www.linkedin.com/company/johnson-&-johnson/" target="_blank" rel="noreferrer noopener" style="font-family: Arial, verdana, 돋움; color: rgb(0, 0, 0); box-sizing: border-box;">https://www.linkedin.com/company/johnson-&-johnson/</a> - J&J Corporate Page: <a href="http://www.jobkorea.co.kr/Company/1605233/Info" target="_blank" rel="noreferrer noopener" style="font-family: Arial, verdana, 돋움; color: rgb(0, 0, 0); box-sizing: border-box;">http://www.jobkorea.co.kr/Company/1605233/Info</a>   “좋아요” & “팔로우” - 존슨앤드존슨 오픈 포지션 및 다양한 소식들을 페이스북, 링크드인 페이지 통해 만나 보시기 바랍니다.   [유의사항] - 서류를 MS-Word 나 PDF 로 된 한 개의 파일로 미리 준비하시기 바랍니다. - 서류 전형 합격자에 한하여 개별 통보합니다. 단, 회사 사정에 따라 지연될 수 있습니다.  - 모집 분야 관련하여 자세한 내용은 J&J 홈페이지에서 확인하시기 바랍니다. www.careers.jnj.com

접수기간	채용시
접수방법	당사홈페이지
이력서양식	지원자 자유이력서 양식
담당자	채용담당자
연락처	02-2094-4500
이메일	recruitment-jnj@its.jnj.com
홈페이지	http://careers.jnj.com
회사주소	[140-702] 서울 용산구 한강로2가 LS용산타워 22-28F

최종수정일 : 2021년 04월 06일

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