[innovative Medicine] R&d, Scientist/manager, Cmc Group, Cmc Sciences, Regulatory Affairs

Johnson & Johnson

Chiyoda, Tokyo, Japan
Not specified
Cmc-regulatory affairs
Prepare application dossiers
Communicate with ha
Johnson & Johnson is seeking a Scientist/Manager for its CMC Group in Regulatory Affairs in Tokyo. The role focuses on conducting change control for approved drug products and preparing application dossiers to facilitate regulatory approvals

Job Summary

  • To conduct change control of approved products appropriately as CMC-regulatory affairs (CMC-RA).
  • To prepare application dossiers for CMC part and to communicate with HA appropriately to contribute in obtaining regulatory approval.
  • To design future operational framework and improve process.

Matching Summary

Match Score: 75

Johnson & Johnson is seeking a Scientist/Manager for its CMC Group in Regulatory Affairs in Tokyo. The role focuses on conducting change control for approved drug products and preparing application dossiers to facilitate regulatory approvals.

Skills & Requirements

Must-have

  • CMC-regulatory affairs
  • prepare application dossiers
  • communicate with HA
  • change control activities
  • regulatory assessment
  • develop regulatory strategy

Nice-to-have

  • inclusive work environment
  • respect diversity and dignity
  • recognize merit
  • continuous manufacturing
  • antibodies
  • cell & gene therapy products

Key Requirements

  • 3 – 5 years’ experience in CMC related arena
  • 8 years’ experience in CMC related arena
  • Experience in change control operations
  • Experience in preparation of CTD
  • Practical level English skill (TOEIC ≥ 700)
  • Bachelor, Master, Doctor

Work Rights

Not specified

Tailored Resume

Cover Letter