[Consumer Health] Associate Regulatory Affairs Manager

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: 존슨앤드존슨컨슈머 (Consumer Health) - 포지션: Associate RA Manager - 근무지: 서울시 용산구 - 근무형태: 정규직 (Regular) [Summary] Proceed the regulatory action of OTC product & other category (Quasi Drug, Cosmetic, etc.) in compliance with regulation for new product launch and maintenance Manage the internal compliance process for OTC product & other category (Quasi Drug, Cosmetic, etc.) including change control, AW development, etc. [Responsibilities] Manage the activities concerned with regulatory action to government regulatory agencies for OTC/Cosmetic/Quasi Drug Establish and communicate the regulatory strategy for new product launch and any variation for current marketed product Communicate and manage the regulatory compliance matters with government regulatory agencies & internal stakeholders Prepare & maintain the regulatory submissions and files and communication with MFDS Interacts with regulatory agency personnel in order to expedite approval of pending application and to resolve regulatory matters Consults with management personnel to establish and prepare appropriate regulatory filings for product approvals Review and advice the regulatory review for artwork and advertisement materials JnJ respects DE&I (Diversity, Equity & Inclusion) [Requirements] Bachelor’s degrees or above. Over 10 year- experience in Regulatory Affairs in pharmaceutical company Pharmacist preferred Good leadership (communication, collaboration, problem solving, project management) Good English communication (Writing & Verbal) ability Johnson & Johnson announced plans to separate our Consumer Health business to create a new publicly traded company. The process of the planned separation is anticipated to be completed within 24 months, and it will be subject to legal requirements including consultation with works councils and other employee representative bodies, as required, and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of a new entity within New Consumer Health and your employment would be governed by New Consumer Health’s employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by New Consumer Health at an appropriate time and subject to any necessary consultation processes. [지원 방법] www.careers.jnj.com 접속 -> Position Number 2206041756W 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: 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 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 At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location. Qualifications - Primary Location South Korea-Seoul-Yongsan-gu- Organization ohnson & Johnson Korea Sales & Distribution LLC (7227) Job Function Regulatory Affairs Requisition ID 2206041756W