〈研究開発・ﾒﾃﾞｨｶﾙｱﾌｪｱｰｽﾞ統括本部〉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 Eli Lilly · Pharma · Kobe, Japan +1

This role focuses on regulatory affairs within the pharmaceutical industry, specifically managing Japan's regulatory policy and intelligence, ensuring compliance with drug and medical device laws, and driving operational excellence within the regulatory affairs department. It involves building relationships with regulatory bodies, contributing to policy strategy, managing submission processes, and enhancing compliance.

What you'd actually do

  1. Build and maintain relationships with key stakeholders such as regulatory authorities and industry groups, continuously monitoring laws, regulations, guidance, and regulatory trends.
  2. Manage the process of maintaining licenses and approvals, and submitting application/notification documents.
  3. Lead the entire document creation and maintenance process, including attached documents and user manuals.
  4. Strengthen compliance with the Pharmaceuticals and Medical Devices Act and related laws and regulations, and provide support and advice to related departments.
  5. Promote efficiency in workflows consistent with global processes and drive the introduction of innovative technology tools.

Skills

Required

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

What the JD emphasized

  • Japanese pharmaceutical regulatory knowledge
  • 3+ years of experience in the pharmaceutical industry or experience working with regulatory authorities
  • Effective communication and negotiation skills in Japanese and English
  • Logical and strategic thinking ability