〈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 UK
Kobe, Japan
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Japan regulatory policy and intelligence
Regulatory delivery and excellence
People excellence and operational effectiveness
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Eli Lilly is seeking a regulatory affairs professional for their Policy and Excellence team in Kobe and Tokyo, Japan. The role involves managing regulatory policies, compliance, and operational effectiveness in the pharmaceutical industry.
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Job Summary
Build and maintain relationships with key stakeholders at regulatory authorities and industry groups, continuously monitoring laws, guidance, and regulatory trends.
Manage the maintenance of licenses and approval documents, and lead the document creation and maintenance process for 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: 75
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Eli Lilly is seeking a regulatory affairs professional for their Policy and Excellence team in Kobe and Tokyo, Japan. The role involves managing regulatory policies, compliance, and operational effectiveness in the pharmaceutical industry.
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Skills & Requirements
Must-have
Japan Regulatory Policy and Intelligence
Regulatory Delivery and Excellence
People Excellence and Operational Effectiveness
Build relationships with regulatory authorities
Monitor regulatory trends
Lead document creation and maintenance
Enhance compliance with pharmaceutical laws
Drive workflow efficiency
Foster innovation and continuous improvement
Nice-to-have
Develop employee capabilities
Promote effective internal communication
Improve operational productivity
Build cross-departmental relationships
Key Requirements
Bachelor's degree in science or related field, or Master's degree in science/medical field
3+ years of experience in the pharmaceutical industry or regulatory authority
Knowledge of Japanese pharmaceutical regulations
Effective communication and negotiation skills in Japanese and English