[Medical Devices] Sr. Regulatory Affairs - Drug

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 (Medical Devices) - 포지션: Sr. Regulatory Affairs Specialist - Drug - 근무지: 서울시 용산구 - 근무형태: 정규직 (Regular) Register new projects in timely manner and ensure regulatory compliance of registered products for pharmaceutical products including biologics. [Responsibilities] Regulatory input to the relevant functions for developing new projects and variation in existing products for pharmaceutical products including biologics. Communicating with regional and global stakeholders to develop registration plan Reviewing the dossier to be submitted to MFDS with product information reflecting opinions from other departments Researching and consolidating regulatory requirements and communicate their information with supervisor and manager. Having a deep product knowledge of the franchise with responsibility. Oversight for initiation, tracking and facilitation new product registrations strategy in Korea and achieve approvals for new projects and variation Managing and reporting NPI and regulatory submission & approval plan to ensure new product registrations Monitoring and submitting regulatory applications for regulatory submission & approval in accordance with regulations and relevant guidelines with limited supervision. Interacting with regulatory agency personnel to expedite approval of pending applications and to resolve regulatory agencies' questions and other correspondence. Communicating information and presents status updates on product/project activities to key internal/external stakeholders when requested. Maintain regulatory compliance of registered products Ensuring all the required label updates and variations up to date in timely manner Ensures compliance with regulatory agency regulations and interpretations. Following up of mandatory requirements for product license maintenance. Communicate local environment change and registration status to local, regional, and global stakeholders. Support in the development of best practices for Regulatory Affairs processes. Supports the RA team in projects. [Requirements] - A Bachelor or higher degree in pharmacy, or equivalent training as a healthcare provider - Min. 5 years of progressive experience in Regulatory Affairs. - Knowledge of regulatory environment and relative law and regulations. - Understanding of regulatory requirements. - Must have the ability to work effectively with limited supervision and process requests/work within required timeframes. - Preference for experiences of biologics(blood products). [지원 방법] www.careers.jnj.com 접속 -> Position Number 2206016054W 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 2206016054W