Jobs

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Management of promotional materials with out-of-date product information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.

Essential 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
  
  

Education: a Bachelor or higher degree in pharmacy, or equivalent training as a healthcare provider

Experiences: 1 + of previous experience in the pharmaceutical industry or medical environment is desired

Training Requirements

Johnson & Johnson requirements (AEPQC, IAPP, ILMW)

Local SOPs (including SUMMIT Training)