[innovative Medicine] R&d, Scientist/manager, Cmc Group, Cmc Sciences, Regulatory Affairs

Johnson & Johnson Innovative Medicine

Chiyoda, Tokyo, Japan
Not specified (likely hybrid or onsite based on company culture).
Cmc regulatory affairs expertise
Change control operations for approved products
Preparation of ctd and application forms
Johnson & Johnson Innovative Medicine is seeking a Scientist/Manager in the CMC Group within Regulatory Affairs to oversee change control and prepare application dossiers for regulatory approval of pharmaceutical products. The ideal candidate should have extensive experience in CMC operations and a strong understanding of regulatory strategies

Job Summary

  • Johnson & Johnson empowers healthcare innovation to build a world where complex diseases are prevented, treated, and cured with smarter and less invasive treatments.
  • The role involves managing change control activities, preparing and reviewing CMC dossiers, and collaborating with stakeholders to obtain regulatory approvals.
  • The company provides an inclusive work environment that respects diversity and dignity, recognizing the merit of each employee.

Matching Summary

Match Score: 85

Johnson & Johnson Innovative Medicine is seeking a Scientist/Manager in the CMC Group within Regulatory Affairs to oversee change control and prepare application dossiers for regulatory approval of pharmaceutical products. The ideal candidate should have extensive experience in CMC operations and a strong understanding of regulatory strategies.

Skills & Requirements

Must-have

  • CMC regulatory affairs expertise
  • Change control operations for approved products
  • Preparation of CTD and application forms
  • Communication with PMDA officials
  • Regulatory strategy development
  • Collaboration with global and local stakeholders

Nice-to-have

  • Experience with chemical and biological products
  • Knowledge of GMP-related regulations
  • Experience in new drug applications
  • CRO management experience
  • Process improvement and operational framework design

Key Requirements

  • 3-5 years experience in CMC pharmaceutical industry
  • 8+ years experience for manager role
  • Practical English skill (TOEIC ≥ 700)
  • Bachelor, Master, or Doctor degree
  • Experience in change control and CTD preparation
  • Experience with chemical and biological products desirable

Work Rights

Not specified

Tailored Resume

Cover Letter