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

Merck & Co., Inc.

Hybrid
Pharmaceutical company experience
Nda filing and review experience
Master of life sciences degree
The role involves developing efficient and high value-added regulatory development strategies for new drugs in Japan aligned with global goals

Job Summary

  • The role involves developing efficient and high value-added regulatory development strategies for new drugs in Japan aligned with global goals.
  • Candidates will serve as the primary contact person for regulatory authorities such as the MHLW and PMDA while coordinating document submissions.
  • The position requires strong communication skills to manage internal schedules and coordinate with US headquarters during regulatory reviews.

Matching Summary

The role involves developing efficient and high value-added regulatory development strategies for new drugs in Japan aligned with global goals.

Skills & Requirements

Must-have

  • Pharmaceutical company experience
  • NDA filing and review experience
  • Master of Life Sciences degree
  • English literature reading capability
  • Email communication with overseas teams

Nice-to-have

  • Positive and logical thinking style
  • Initiative and action-oriented approach
  • Knowledge of Pharmaceutical Affairs Regulations
  • Experience with MHLW and PMDA interactions

Key Requirements

  • Master's degree in Life Sciences
  • Prior experience in pharmaceutical development
  • Proven track record in NDA filing and review
  • Fluency in English for technical correspondence

Work Rights

Not specified

Sponsorship: available

Tailored Resume

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