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[Janssen] Regulatory Affairs Specialist (Contractor)

Auris Health

Auris Health

Legal
Seoul, South Korea
Posted on Thursday, September 7, 2023
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Description

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 pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

1. Position: RA Specialist

2. Sector: Janssen (한국얀센)

3. Location: Yongsan-gu, Seoul

4. Work Type: Fixed-term (계약직)

 

 

To register products in a timely manner in support of business growth and to maintain full compliance of products with regulatory requirements.

[Job scope]

- New product registration

- CMC variations of approved products

- Label updates (including CCDS update)

- Clinical trial application to MFDS

- Support of regulatory activity in license management

[Key Accountability]

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

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

Label updates

- Reviewing the documents forwarded from regional RA and submitting to MFDS

- Timely notification of label changes in accordance with appropriate SOP

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

- Management of promotional materials with out of date product information

Support the regulatory activities in license management, if any.

- Assist in SOP development and review.

- Provide regulatory input to product lifecycle planning.

[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: 1~3 years of previous experience on the pharmaceutical industry or medical environment 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]
www.careers.jnj.com -> Requisition number 2306136057W 검색 -> 해당 모집 공고 클릭 후, “Apply Now”

[제출 서류]

영문 자유 양식의 이력서/경력기술서/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. 
- 모집 분야 관련하여 자세한 내용은 J&J 홈페이지에서 확인하시기 바랍니다. 

www.careers.jnj.com

Qualifications

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