Johnson & Johnson is on FGB’s Best Companies for Women of 2020.
FGB'ers gave this company a 4.3/5 in overall job satisfaction
FGB’ers working at Johnson & Johnson rated their manager’s support a 4.4/5
Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).
Global exercise reimbursement.
Two weeks off (one of them fully paid) for volunteer work.
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: 존슨앤드존슨메디칼 (J&J MedTech) - 포지션: Sr. Regulatory Affairs Specialist - 근무지: 서울시 용산구 - 근무형태: 정규직 (Regular) [Summary] Coordinates, compiles, and submits applications of new products or changes to the approved products to the regulatory agencies. Ensures compliance with regulatory agency regulations and interpretations. Prepares responses to regulatory agencies' questions and other correspondence. Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines. Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides. Provides solutions to a variety of problems of moderate scope and complexity. Organizes and maintains reporting schedules of new product registration, changes in products, projects, etc.. [Responsibilities] Functional and Technical Competencies Prepares, submits, and monitors applications of new products, changes in approved products, and KGMP. Applies knowledge in regulations and characteristics of products to prepare compliant regulatory strategies and to assess regulatory impact on products as product life-cycle management. Interacts with regulatory agency personnel in order to expedite approval applications and to resolve regulatory matters with limited supervision. Follows up of mandatory requirements for registration: local certificates, importation of samples, local testing, etc. with limited supervision. Ensures Korean label contents and approves the final Korean label artwork. Researches and consolidates regulatory requirements and actively communicates with the supervisor and the manager. Provides training and limited supervision of contract resources, as needed. Supports and contributes to team, company, regional, global, cross-sector projects. Shares best practices and learnings with the team in terms of RA processes and templates, product registration, projects, etc. Leverages experience and learnings from the past to make reasonable decisions in the challenging situations. Understands business environment and business strategies and develops effective and results-oriented regulatory strategic plans that are in line with business objectives. Manages specific project steps to meet milestones independently or with limited supervision. Understands trends in the healthcare environment, changes in external marketplace, and competitors’ tendency and the influence of social, economic, and political factors on business and regulatory environment. Leadership Competencies Effectively manages priorities and strongly collaborates with stakeholders to make the best possible decision. Consistently manages large amount of changing, complex, ambiguous information and makes reasonable decisions in a timely manner. Engages with external stakeholders and demonstrates conviction, proactivity, and persistence especially when influencing others and overcoming resistance. Creates compelling positions in negotiations that build support and consensus with key stakeholders. Builds and leverages internal and external networks with colleagues, cross-functional partners, and industry contacts to identify opportunities and open communication channels. Creates and delivers verbal and written communication with highlighting the most pertinent information for targeted stakeholders. Supports stakeholders to take actions if needed. Acts with speed, agility and accountability in the decision making and balances short and long-term decisions and activities. Demonstrates an enterprise-wide mindset. Experiments and learns from trying new approaches and applying the new ideas from insights [Requirements] A minimum Bachelor’s degree Min. 3 years of experience in Regulatory Affairs Understanding in regulatory requirements, laws, standards, and environment The incumbent must have the ability to work effectively with limited supervision and process requests/work within required timeframes Strong communication and interpersonal skills Experience in a multi-national or regional company is preferred Fluent in both verbal and written English [지원 방법] www.careers.jnj.com 접속 -> Position Number 2206038246W 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 Johnson & Johnson Medical Korea (Ltd.) (7225) Job Function Regulatory Affairs Requisition ID 2206038246W
Child care benefits
Short term disability