Pharmaceutical Regulatory Leader
中外製薬株式会社
- Regulatory Affairs
- FDA
- PMDA
- IND
- EMA
- CTA
- Pharmaceutical expertise
- Negotiation skill
- Problem Solving Approach
- Global regulatory activities
- Cross-functional project team
- ICH GL
- NDA filings
- Korea
- Taiwan
- China
- MHLW
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Tokyo
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1,001 to 10,000
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Company Homepage
Company Info
Job Summary
As a pharmaceutical regulatory function leader, you will be responsible for the development of pharmaceuticals, medical care, and other medical fields such as immunotherapy and new modalities, and will conduct regulatory applications and inspections both domestically and internationally, and collaborate with overseas subsidiaries and partners as a global regulatory leader. The required experience includes over 5 years of pharmaceutical regulatory experience, experience in cross-functional project team management, and experience in international pharmaceutical regulatory affairs, and a TOEIC score of 730 points or higher is required.Duties
As a pharmaceutical regulatory function leader, you will be responsible for the development of pharmaceuticals, medical care, and other medical fields such as immunotherapy and new modalities, and will conduct regulatory applications and inspections both domestically and internationally, and will establish a regulatory application/inspection system for the development of pharmaceuticals~market sales, and collaborate with overseas subsidiaries and partners as a global regulatory leader.Login to see all information about offers.
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