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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 

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

Legal Entity

• Innovative Medicine

Job Type

• Regular

Application Documents

• Free-form resume AND cover letter is preferred (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.

#LI-Hybrid #LI-SK3

 

 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Business Behavior, Business Writing, Collaboration, Communication, Confidentiality, Data Reporting, Data Savvy, Detail-Oriented, Execution Focus, Legal Support, Medicines and Device Development and Regulation, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments