[innovative Medicine] Associate Ra Manager

Johnson & Johnson

Seoul, Republic of Korea
Hybrid
New product registration with mfds
Cmc variations dossier review
Label updates and ccds management
The role involves developing treatments and pioneering the path from lab to life while championing patients every step of the way

Job Summary

  • The role involves developing treatments and pioneering the path from lab to life while championing patients every step of the way.
  • Key responsibilities include reviewing dossiers, submitting applications to the Ministry of Food and Drug Safety (MFDS), and managing label updates.
  • Candidates must possess sound knowledge of general medicine or pharmacy along with fluency in both English and local languages.

Matching Summary

The role involves developing treatments and pioneering the path from lab to life while championing patients every step of the way.

Skills & Requirements

Must-have

  • New product registration with MFDS
  • CMC variations dossier review
  • Label updates and CCDS management
  • Clinical trial application submission
  • Fluency in English and Korean

Nice-to-have

  • Strong interpersonal communication skills
  • Ability to negotiate with stakeholders
  • Knowledge of Janssen Korea products
  • Experience in license management support
  • Familiarity with drug development principles

Key Requirements

  • Bachelor degree in pharmacy or equivalent healthcare training
  • 5-7+ years of regulatory affairs experience
  • Proficiency in Global and Local SOPs

Work Rights

Preference for veterans and persons with disabilities; Not specified for others

Tailored Resume

Cover Letter