Johnson & Johnson Careers

[Consumer] Sr. Regulatory Affairs Specialist

Yongsan-gu, South Korea
Regulatory Affairs


Job Description

Requisition ID: 1905714874W

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. 포지션: Sr. Regulatory Affairs Specialist
2. 계열사: 존슨앤드존슨 컨슈머 (Consumer)

3. 근무지: 서울시 용산구

4. 근무 기간: Fixed Term 1년 (평가 후 연장 가능) 

 

[Summary]

1. Proceed the regulatory action of OTC product in compliance with regulation for new product launch and maintenance

2. Manage the internal compliance process for OTC product including change control, AW development, etc.

 

[Responsibilities]

1. Manage the activities concerned with regulatory action to government regulatory agencies for OTC

2. Establish and communicate the regulatory strategy for new product launch and any variation for current marketed product

3. Communicate and manage the regulatory compliance matters with government regulatory agencies & internal stakeholders

4. Prepare & maintain the regulatory submissions and files and communication with MFDS

5. Interacts with regulatory agency personnel in order to expedite approval of pending application and to resolve regulatory matters

6. Consults with management personnel to establish and prepare appropriate regulatory filings for product approvals

7. Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines

8. Review and advice the regulatory review for artwork and advertisement materials

 

[Requirements]

1. Bachelor’s degrees or above.

2. Over 3 year- experience in Regulatory Affairs in pharmaceutical company

3. Technical knowledge in Chemistry, Chemical engineering or pharmacy

4. Good leadership (communication, collaboration, problem solving, project management)

5. Good English communication (Writing & Verbal) ability

 

[지원 방법]
www.careers.jnj.com 접속 -> Position Number 1905714874W 검색 -> 해당 모집 공고의 “Apply Now” 클릭 후 온라인 지원 프로세스 진행


[제출 서류]

영문 자유 양식의 이력서/자기소개서


[서류 마감일] 
채용시 마감

 


[유의사항] 
- 서류를 MS-Word 나 PDF 로 된 한 개의 파일로 미리 준비 하시기 바랍니다.
- 서류 전형 합격자에 한하여 개별 통보합니다. 단, 회사 사정에 따라 지연 될 수 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
See above
Primary Location
South Korea-Seoul-Yongsan-gu-
Organization
ohnson & Johnson Korea Sales & Distribution LLC (7227)
Job Function
Regulatory Affairs
Requisition ID
1905714874W