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

Merck & Co., Inc.

Rahway, NJ, USA
Hybrid
Pharmaceutical company experience
Nda filing and review experience
Master of life sciences degree
Merck & Co., Inc. is seeking a Senior Scientist in R&D Regulatory Affairs to develop regulatory strategies for new drug applications in Japan. The ideal candidate should have a background in pharmaceutical development and experience in regulatory submissions, as well as strong communication skills and a degree in life sciences

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, submission, and review of NDA documents and consultation materials.

Matching Summary

Match Score: 85

Merck & Co., Inc. is seeking a Senior Scientist in R&D Regulatory Affairs to develop regulatory strategies for new drug applications in Japan. The ideal candidate should have a background in pharmaceutical development and experience in regulatory submissions, as well as strong communication skills and a degree in life sciences.

Skills & Requirements

Must-have

  • Pharmaceutical company experience
  • NDA filing and review experience
  • Master of Life Sciences degree
  • English literature reading skills
  • Cross-border email communication

Nice-to-have

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

Key Requirements

  • Experience at pharmaceutical or drug development companies
  • Prior experience in filing and regulatory review
  • Master's degree in Life Sciences or higher
  • Proficiency in English for technical correspondence

Work Rights

Not specified

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