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Regulatory Affairs

Our Mission Statement

Regulatory Affairs mission is to pursue scientific progress and identify unmet medical needs for patients. We develop and drive innovative strategies to support speedy access to novel therapies for patients in need.

Chugai Pharma USA Regulatory Affairs mission is to use our expertise in global regulatory strategy to progress innovation science and improve regulatory decision-making, providing better drugs to patients in need. We also track ongoing regulation changes and push to arrive at positive regulatory outcomes for Chugai’s drugs in development.

Regulatory Affairs focuses on delivering positive outcomes through a model that reflects Chugai Pharma USA’s organization and ensures complete oversight of our product portfolio with high quality and compliance to ensure First-Time-Right submissions for FDA and Health Canada.

Chugai Pharma USA Regulatory Affairs focuses on delivering outcomes through a model that reflects Chugai Pharma USA’s organization. We ensure that our regulatory submissions and life cycle management activities are of high quality with compliance oversight. We always strive for First-Time-Right submissions, especially for North America but also globally.

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