Japan_development Pharmaceutical Affairs

Celltrion Healthcare

Ctd and fd application document creation
Regulatory authority correspondence
Cmc regulatory support
The role involves managing regulatory affairs and quality assurance work centered on the product life cycle of biopharmaceuticals

Job Summary

  • The role involves managing regulatory affairs and quality assurance work centered on the product life cycle of biopharmaceuticals.
  • Responsibilities include creating and reviewing CTD and FD application documents while coordinating with authorities and internal teams.
  • The position requires negotiating with manufacturers to ensure approved content aligns perfectly with manufacturing methods.

Matching Summary

The role involves managing regulatory affairs and quality assurance work centered on the product life cycle of biopharmaceuticals.

Skills & Requirements

Must-have

  • CTD and FD application document creation
  • Regulatory authority correspondence
  • CMC regulatory support
  • Product life cycle management
  • Manufacturer coordination

Nice-to-have

  • Experience in biosimilar markets
  • Strong internal and external communication
  • New product introduction project participation

Key Requirements

  • Experience with pharmaceutical applications and change notifications
  • Knowledge of CMC regulatory support processes
  • Ability to handle regulatory consultation work

Work Rights

Not specified

Tailored Resume

Cover Letter