[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
Johnson & Johnson is seeking an Associate RA Manager in Seoul, Korea, to support regulatory affairs in their Innovative Medicine division. The role involves new product registration, managing CMC variations, label updates, and clinical trial applications, requiring strong knowledge of regulatory requirements and effective communication skills

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 and fluency in both written and spoken English alongside local languages.

Matching Summary

Match Score: 85

Johnson & Johnson is seeking an Associate RA Manager in Seoul, Korea, to support regulatory affairs in their Innovative Medicine division. The role involves new product registration, managing CMC variations, label updates, and clinical trial applications, requiring strong knowledge of regulatory requirements and effective communication skills.

Skills & Requirements

Must-have

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

Nice-to-have

  • Strong interpersonal communication skills
  • Ability to negotiate with internal customers
  • Experience with Janssen Korea products
  • Knowledge of global regulatory standards

Key Requirements

  • Bachelor degree in pharmacy or equivalent healthcare training
  • 5-7+ years of previous experience in regulatory affairs
  • Knowledge of local regulatory requirements and global standards

Work Rights

Not specified

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