R&d Regulatory Affairs Sr. Scientist（開発薬事）

539

Tokyo, Japan
Hybrid
Domestic development regulatory strategy
Contact with regulatory authorities
Document quality improvement
Develop an efficient and high value-added Japan regulatory development strategy in line with global strategies

Job Summary

  • Develop an efficient and high value-added Japan regulatory development strategy in line with global strategies.
  • Contribute to improving documents quality submitted by authorities through review on CTD, PMDA consultation documents, responses to inquiries, etc.
  • Coordination including HQ when interacting authorities (30-days review, PMDA consultation, NDA submission, NDA review).

Matching Summary

Develop an efficient and high value-added Japan regulatory development strategy in line with global strategies.

Skills & Requirements

Must-have

  • domestic development regulatory strategy
  • contact with regulatory authorities
  • document quality improvement
  • regulatory information collection and analysis
  • internal coordination with HQ

Nice-to-have

  • positive attitude
  • logical thinking
  • initiative and action-oriented

Key Requirements

  • Master of Life Sciences or above
  • Filing/Review experiences
  • English skill for literature reading and email communication

Work Rights

Not specified

Tailored Resume

Cover Letter