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

Merck & Co., Inc.

Japan
Hybrid
Pharmaceutical company experience
Drug filing and review experience
Master of life sciences degree
Merck & Co., Inc. is seeking an R&D Regulatory Affairs Senior Scientist in Japan, responsible for developing regulatory strategies for new drug applications in alignment with global standards. The ideal candidate will have experience in pharmaceutical development, a strong understanding of regulatory affairs, and proficiency in English

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, managing submissions and inquiries.
  • This position requires coordinating internal schedules with US headquarters during critical regulatory interactions like 30-day reviews and NDA submissions.

Matching Summary

Match Score: 85

Merck & Co., Inc. is seeking an R&D Regulatory Affairs Senior Scientist in Japan, responsible for developing regulatory strategies for new drug applications in alignment with global standards. The ideal candidate will have experience in pharmaceutical development, a strong understanding of regulatory affairs, and proficiency in English.

Skills & Requirements

Must-have

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

Nice-to-have

  • Positive thinking attitude
  • Logical thinking skills
  • Initiative and action-oriented approach
  • Knowledge of Pharmaceutical Affairs Regulations

Key Requirements

  • Experience at a pharmaceutical company
  • Filing and review experience
  • Master's degree in Life Sciences
  • Basic knowledge of pharmacy or medicine

Work Rights

Not specified

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