＜ダイアベティスケア事業部＞ra Manager

Abbott

Tokyo, Japan
Regulatory compliance
Regulatory submissions
Japanese regulatory authorities
Ensure compliance with all ADC products' regulations and respond promptly to administrative instructions, contributing to the achievement of organizational business objectives by supporting quality assurance in ADC Japan's sales activities

Job Summary

  • Ensure compliance with all ADC products' regulations and respond promptly to administrative instructions, contributing to the achievement of organizational business objectives by supporting quality assurance in ADC Japan's sales activities.
  • Plan and lead regulatory affairs for all ADC products, including creating regulatory submission plans aligned with sales plans, preparing application materials, and leading projects to obtain approval.
  • Build and maintain good relationships with Japanese regulatory authorities and effectively communicate according to ADC's Quality Management System (QMS) procedures.

Matching Summary

Ensure compliance with all ADC products' regulations and respond promptly to administrative instructions, contributing to the achievement of organizational business objectives by supporting quality assurance in ADC Japan's sales activities.

Skills & Requirements

Must-have

  • Regulatory compliance
  • Regulatory submissions
  • Japanese regulatory authorities
  • Advertising and promotion review
  • Quality Management System

Nice-to-have

  • Proactive communication
  • Adaptability
  • Analytical skills
  • Teamwork
  • Judgment

Key Requirements

  • 5+ years of regulatory affairs experience in the medical device industry
  • Bachelor's degree or higher in Science, Pharmacy, Biology, Food Chemistry, or Chemistry
  • Effective Japanese reading and writing communication skills
  • Sufficient business English (speaking/writing) ability (TOEIC 700+)

Work Rights

Not specified

Tailored Resume

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