한국얀센 · [Janssen] Regulatory Affairs Specialist

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.


1. 포지션: Regulatory Affairs Specialist
2. 계열사: 한국얀센 (Janssen) 
3. 근무지: 서울시 용산구
4. 근무 형태: Fixed Term 


[Summary] 
– New product registration 
– CMC variations of approved products
– Label updates (including CCDS update)
– Clinical trial application to MFDS
– Support of regulatory activity in license management


[Responsibilities] 
1. New product registration 
– Communicating with regional RA to get the dossier in a timely manner
– Reviewing the dossier and submitting to MFDS with product information reflecting opinions from other departments
– Timely submission of supplemental documents requested by MFDS, if any 
2. CMC variations of approved products
– Reviewing the dossier and submitting to MFDS in line with Q&C
– Timely submission of supplemental documents requested by MFDS, if any
3. Label updates 
– Reviewing the documents forwarded from regional RA and submitting to MFDS 
– Timely notification of label changes in accordance with appropriate SOP
4. Clinical trial application to MFDS
– Communicating with GCO and regional RA to get the dossier in a timely manner
– Reviewing the dossier and submitting to MFDS
– Timely submission of supplemental documents requested by MFDS, if any
– Management of promotional materials with out of date product information 
5. Support the regulatory activities in license management, if any.
– Assist in SOP development and review.
– Provide regulatory input to product lifecycle planning.


*Key Working Relationships
1. Internal
– All departments of Janssen Korea, especially production, Q&C, logistics, marketing, PR, GCO, Market Access, Medical, etc.
– Regional RA
2. External
– Ministry of Food and Drug Safety
– Healthcare professionals


[Requirements]
1. Education: a Bachelor or higher degree in pharmacy, or equivalent training as a healthcare provider
2. Experiences: previous experience on the pharmaceutical industry or medical environment is desired
3. Essential knowledge & skills
– Sound knowledge of general medicine or pharmacy and clinical practice
– Knowledge of local regulatory requirements/guidelines and global standards
– Fluency in written and spoken English in addition to local language(s)
– Awareness and familiarity with industry principles of drug development and pharmacology
– Proficiency in Global and Local SOPs
– Knowledge of the Janssen Korea products
– Good interpersonal communication skills
– Ability to negotiate and communicate with internal and external customers


[지원 방법] 
http://www.careers.jnj.com 접속 -> Position Number 2206095204W 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 Careers 유튜브 채널 : https://www.youtube.com/channel/UCZEsWOZwbcjcXHrgYq7sP4Q
– J&J Korea Facebook: https://www.facebook.com/JNJCareersKorea/
– J&J Linkedin: https://www.linkedin.com/company/johnson-&-johnson/
– J&J Corporate Page: http://www.jobkorea.co.kr/Company/1605233/Info


[유의사항] 
– 서류를 MS-Word 나 PDF 로 된 한 개의 파일로 미리 준비 하시기 바랍니다.
– 서류 전형 합격자에 한하여 개별 통보합니다. 단, 회사 사정에 따라 지연 될 수 있습니다. 
– 온라인 접수시 “Create Your Account” 를 통해 개인 이메일 계정을 등록하신 후 온라인 지원 프로세스를 진행할 수 있습니다. Ex) G-mail/Naver/Daum 등
– 모집 분야 관련하여 자세한 내용은 J&J 홈페이지에서 확인하시기 바랍니다. http://www.careers.jnj.com

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