Job Information
J&J Family of Companies [Janssen] Associate Regulatory Affairs Manager in Seoul, South Korea
[Janssen] Associate Regulatory Affairs Manager - 2406194779W
Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in pharmaceutical, medical devices and diagnostics markets, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at https://www.jnj.com/ .
DE&I Statement
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
포지션: Associate Regulatory Affairs Manager
계열사: 얀센 (Janssen)
근무지: 서울시 용산구
근무 형태: Regular
[Job Scope]
q New product registration
q CMC variations of approved products
q Label updates (including CCDS update)
q Clinical trial application to MFDS
q Support of regulatory activity in license management
[Main responsibilities]
q 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
q 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
q Label updates
Reviewing the documents forwarded from regional RA and submitting to MFDS
Timely notification of label changes in accordance with appropriate SOP
q 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
q Management of promotional ma support the regulatory activities in license management, if any.
Trials with out-of-date product information
q Support the regulatory activities in license management, if any.
Assist in SOP development and review
Provide regulatory input to product lifecycle planning
Requirement
ESSENTIONAL 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
QUALIFICATIONS
Education: A Bachelor or higher degree in pharmacy, or equivalent training as a healthcare provider
Experiences: 57 years of previous experience on regulatory affairs is desired
TRAINING REQUIREMENTS
Johnson & Johnson requirements (AEPQC, IAPP, ILMW)
Local SOPs (including SUMMIT Training)
KEY WORKING RELATIONSHIPS
Internal
All departments of Janssen Korea, especially production, Q&C, logistics, marketing, PR, GCO, Market Access, Medical, etc.
Regional RA
External
Ministry of Food and Drug Safety
Healthcare professionals
[JD 확인 및 지원 방법 ]
https://careers.jnj.com (https://careerhub.jnj.com) -> Requisition number “2406194779W”검색 -> 해당 모집 공고 클릭 후, “Apply Now”
[ 제출 서류 ]
영문 자유 양식의 이력서/경력기술서/자기소개서
[ 서류 마감일 ]
채용시 마감
[ 유의사항 ]
국가보훈 대상자 및 장애인은 관련 서류 제출 시 관계 법령에 의거하여 우대합니다.
서류 전형 합격자에 한하여 개별 통보합니다. 단, 회사 사정에 따라 지연될 수 있습니다.
입사 지원 서류에 허위 사실이 발견될 경우, 채용 확정 이후라도 채용이 취소될 수 있으며 향후 채용이 제한됩니다.
제출된 서류는 반환되지 않으며, 별도 요청 시 삭제합니다.
www.careers.jnj.com
Qualifications
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Primary Location Asia Pacific-South Korea-Seoul-Yongsan-gu
Organization Janssen Korea, Ltd. (7220)
Job Function Regulatory Affairs
Req ID: 2406194779W