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Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Seoul, Korea, Republic of

Job Description:

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 ACCOUNTABILITIES

• 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  - Management of promotional materials with out of date product information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: 3~5 + 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

#LI-Hybrid

Legal Entity

Innovative Medicine(Formerly Janssen)

Job Type

Regular

Application Documents

Free-form resume AND cover letter is required (in Korean or English).

Application Deadline

Open until the position is filled.

Notes

• Preference will be given to individuals subject to national veterans’ benefits and persons with disabilities upon submission of relevant documents as per applicable laws.
• Only candidates who pass the resume screening will be notified individually. However, notifications may be delayed due to company circumstances.
• If any false information is found in the application documents, the hiring may be canceled even after the offer is confirmed, and future applications may be restricted.
• Submitted documents will not be returned and will be deleted upon request.

 

 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Business Behavior, Business Writing, Communication, Confidentiality, Data Reporting, Detail-Oriented, Legal Support, Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Teamwork