〈研究開発・メディカルアフェアーズ統括本部〉薬事本部 Policy And Excellence/担当・担当課長・専門課長/神戸本社・東京支社

Eli Lilly

Kobe, Japan
On-site
Japan regulatory policy and intelligence
Regulatory delivery and excellence
Global regulatory affairs collaboration
Eli Lilly is seeking a qualified candidate for a regulatory affairs position in their Kobe or Tokyo offices. This role involves developing regulatory policies, ensuring compliance, and promoting operational excellence within the pharmaceutical industry

Job Summary

  • Build and maintain relationships with key stakeholders at regulatory agencies and industry groups, continuously monitoring laws, guidelines, and regulatory trends.
  • Manage the maintenance of permits and approval documents, and lead the process for creating and maintaining documents such as package inserts and user manuals.
  • Support the design and provision of development opportunities for the Regulatory Affairs department members, ensuring appropriate regulatory-related training and talent development.

Matching Summary

Match Score: 85

Eli Lilly is seeking a qualified candidate for a regulatory affairs position in their Kobe or Tokyo offices. This role involves developing regulatory policies, ensuring compliance, and promoting operational excellence within the pharmaceutical industry.

Skills & Requirements

Must-have

  • Japan Regulatory Policy and Intelligence
  • Regulatory Delivery and Excellence
  • Global Regulatory Affairs collaboration
  • Industry association representation

Nice-to-have

  • Innovation and continuous improvement culture
  • Employee engagement and development
  • Cross-departmental collaboration

Key Requirements

  • Bachelor's degree in science or engineering field or Master's degree in science or medical field
  • 3+ years of experience in the pharmaceutical industry or regulatory agency
  • Knowledge of Japanese pharmaceutical regulations
  • Effective communication and negotiation skills in Japanese and English
  • Logical and strategic thinking ability

Work Rights

Not specified

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