[innovative Medicine] R&d, Specialist/manager, Regulatory Strategy & Liaison Group, Regulatory Development, Regulatory Affairs

J&J FAMILY OF COMPANIES

Chiyoda, Tokyo, Japan
Not specified
Japanese regulatory strategy development
Pmda and mhlw interaction experience
Ctd dossier preparation and submission
Johnson & Johnson is seeking a Regulatory Strategy & Liaison Group Specialist/Manager in Chiyoda, Tokyo, to lead Japanese regulatory strategies and contribute to drug development processes. The ideal candidate will possess significant experience in regulatory affairs, particularly within the pharmaceutical industry, and have strong communication skills in both Japanese and English

Job Summary

  • This role leads the Japanese regulatory strategy and target labeling for Johnson & Johnson's Innovative Medicine division.
  • The incumbent is responsible for preparing Common Technical Document (CTD) submissions and managing interactions with Japanese Health Authorities like PMDA and MHLW.
  • Candidates must possess strong bilingual communication skills in Japanese and business-level English to facilitate global regulatory alignment.

Matching Summary

Match Score: 85

Johnson & Johnson is seeking a Regulatory Strategy & Liaison Group Specialist/Manager in Chiyoda, Tokyo, to lead Japanese regulatory strategies and contribute to drug development processes. The ideal candidate will possess significant experience in regulatory affairs, particularly within the pharmaceutical industry, and have strong communication skills in both Japanese and English.

Skills & Requirements

Must-have

  • Japanese regulatory strategy development
  • PMDA and MHLW interaction experience
  • CTD dossier preparation and submission
  • Target labeling creation and negotiation
  • Clinical study design input for Japan

Nice-to-have

  • Global regulatory team collaboration
  • Cross-functional leadership skills
  • Strategic contingency planning
  • Business-level English communication
  • Proactive adaptation to changing regulations

Key Requirements

  • Bachelor's degree in pharmacy or life science
  • Minimum 6 years R&D pharmaceutical industry experience
  • 2+ years specific regulatory experience
  • Knowledge of Japanese pharmaceutical regulations
  • Fluency in Japanese and business English

Work Rights

Not specified

Tailored Resume

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