Johnson & Johnson Careers

[Janssen] Regulatory Submissions Lead

Yongsan-gu, Seoul
Regulatory Affairs


Job Description

Requisition ID: 1805635788W

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. Job Title: Regulatory Submissions Lead
2. Sector:
한국얀센 (Janssen)
3. Location: Yongsan, Seoul


 

The Regulatory Submissions Lead is a member of the Regulatory Management Centre and is responsible for compilation of all life cycle management activities to regulatory agencies in Asia Pacific. The position reports to the RMC Submissions Manager. 

 

[Responsibilities]

- Facilitate discussion with the LOC on CMC variation / label change from global dispatch to local submission

- Connect with Global, Regional and Local RA colleagues on local dossier requirements

- Prepare submission plan based on global dispatch and country specific requirements

- Prepare submission-ready dossier based on local understanding and recipe book

- Work closely with LOC to ensure country specific inputs are updated into recipe book

- Request country specific documents such as data administration, translation, artwork, samples and certificate

- Manage and monitor HA query process

- Connect with RRL, Labeling team and LOC on content deviation process

- Work with Planning and Compliance team and Artwork team and LOC on post-approval activities  

 

[Requirements]

- University degree in pharmacy, life sciences or equivalent field

- 5 years or more relevant work experience in Regulatory Affairs/Government Affairs/Quality/Compliance/Manufacturing in medical or pharmaceutical companies

- Experience of working in a virtual team and/or global organization

- Previous experience in RA role as Associate, Professional or similar role is of advantage

- Fluent in written and spoken English

- Knowledge of local regulations and international standards

- Able to make independent decisions

- Able to analyze (complex) information and situations and to formulate clear solutions.

- Constructive team player

- Good communication and collaboration required


 

[Application]
www.careers.jnj.com 접속 -> Position Number 1805635788W 검색 -> 해당 모집 공고의 “Apply Now” 클릭 온라인 지원 프로세스 진행

[제출 서류]

영문 자유 양식의 이력서/자기소개서


[서류 마감일] 
채용시 마감

 

[유의사항] 
- 서류를 MS-Word PDF 개의 파일로 미리 준비 하시기 바랍니다.
- 서류 전형 합격자에 한하여 개별 통보합니다. , 회사 사정에 따라 지연 있습니다. 

- 온라인 접수시 “Create Your Account” 통해 개인 이메일 계정을 등록하신 온라인 지원 프로세스를 진행할 있습니다. Ex) G-mail/Naver/Daum
- 모집 분야 관련하여 자세한 내용은 J&J 홈페이지에서 확인하시기 바랍니다.

www.careers.jnj.com


Qualifications
-
Primary Location
South Korea-Seoul-Yongsan-gu
Organization
Janssen Korea, Ltd. (7220)
Job Function
Regulatory Affairs
Requisition ID
1805635788W