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

Merck & Co., Inc.

Hybrid
Experience in pharmaceutical company
Nda filing and review experience
Master's degree in life sciences
The role involves developing efficient and high value-added Japan regulatory development strategies aligned with global plans

Job Summary

  • The role involves developing efficient and high value-added Japan regulatory development strategies aligned with global plans.
  • Candidates will serve as the primary contact person for regulatory authorities such as MHLW and PMDA.
  • Responsibilities include coordinating the preparation and submission of NDA documents and managing interactions with US headquarters.

Matching Summary

The role involves developing efficient and high value-added Japan regulatory development strategies aligned with global plans.

Skills & Requirements

Must-have

  • Experience in pharmaceutical company
  • NDA filing and review experience
  • Master's degree in Life Sciences
  • English literature reading capability
  • Email communication with overseas teams

Nice-to-have

  • Positive attitude and initiative
  • Logical thinking skills
  • Knowledge of Pharmaceutical Affairs Regulations
  • Proactive action-oriented mindset

Key Requirements

  • Master of Life Sciences or above
  • Prior experience at a pharmaceutical company
  • Filing and review experience required

Work Rights

Not specified

Tailored Resume

Cover Letter