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

MOBS Lab

Hybrid
Domestic regulatory strategy
Contact with regulatory authorities
Document quality improvement
MOBS Lab is seeking a Senior Scientist in R&D Regulatory Affairs to develop and implement regulatory strategies for pharmaceutical products in Japan. The ideal candidate should possess experience in regulatory submissions and communication with authorities, along with a strong background in life sciences

Job Summary

  • Develop an efficient and high value-added Japan regulatory development strategy in line with global strategies.
  • Contribute to improving documents quality submitted by authorities through review on CTD, PMDA consultation documents, responses to inquiries, etc.
  • Coordination including HQ when interacting authorities (30-days review, PMDA consultation, NDA submission, NDA review).

Matching Summary

Match Score: 85

MOBS Lab is seeking a Senior Scientist in R&D Regulatory Affairs to develop and implement regulatory strategies for pharmaceutical products in Japan. The ideal candidate should possess experience in regulatory submissions and communication with authorities, along with a strong background in life sciences.

Skills & Requirements

Must-have

  • domestic regulatory strategy
  • contact with regulatory authorities
  • document quality improvement
  • submission coordination
  • regulatory information analysis
  • internal coordination with HQ

Nice-to-have

  • positive attitude
  • logical thinking
  • proactive and action-oriented

Key Requirements

  • Pharmaceutical company experience
  • Filing/Review experiences
  • Master of Life Sciences or above
  • Basic knowledge about pharmacy or medicine
  • English communication skills
  • Communication skills

Work Rights

Not specified

Tailored Resume

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