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

Merck & Co., Inc.

Rahway, NJ, USA
**
Pharmaceutical company experience
Nda filing and review experience
Master of life sciences degree
** Merck & Co., Inc. is seeking an R&D Regulatory Affairs Senior Scientist to develop and implement regulatory strategies for new drug approvals in Japan. The ideal candidate will have experience in pharmaceutical development, strong communication skills, and a robust understanding of pharmaceutical regulations. **

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 MHLW and PMDA while coordinating document submissions.
  • The position requires strong English communication skills to collaborate with overseas teams and manage complex approval processes.

Matching Summary

Match Score: 75

** Merck & Co., Inc. is seeking an R&D Regulatory Affairs Senior Scientist to develop and implement regulatory strategies for new drug approvals in Japan. The ideal candidate will have experience in pharmaceutical development, strong communication skills, and a robust understanding of pharmaceutical regulations. **

Skills & Requirements

Must-have

  • Pharmaceutical company experience
  • NDA filing and review experience
  • Master of Life Sciences degree
  • English literature reading capability
  • MHLW and PMDA interaction

Nice-to-have

  • Positive and logical thinking style
  • Initiative and action-oriented approach
  • Knowledge of Pharmaceutical Affairs Regulations
  • Cross-border communication skills

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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