Atsushi Ito serves as the Assistant Manager of CMC Regulatory Affairs at Pharmaceutical Company 2, where he leverages his extensive expertise in regulatory affairs and quality assurance to navigate the complex landscape of pharmaceutical compliance. With a strong foundation in the creation and submission of...
Atsushi Ito serves as the Assistant Manager of CMC Regulatory Affairs at Pharmaceutical Company 2, where he leverages his extensive expertise in regulatory affairs and quality assurance to navigate the complex landscape of pharmaceutical compliance. With a strong foundation in the creation and submission of regulatory documentation, Atsushi is adept at preparing Common Technical Document (CTD) submissions and managing the intricacies of manufacturing and marketing authorization applications. His role involves not only the meticulous compilation of CTD materials but also crafting responses to regulatory inquiries, ensuring that all communications with authorities such as the Pharmaceuticals and Medical Devices Agency (PMDA) and the FDA are clear, comprehensive, and compliant.
Atsushi's current projects include overseeing the preparation of documentation for both major and minor amendments to existing approvals, demonstrating his ability to adapt to evolving regulatory requirements. His commitment to continuous improvement is evident in his proactive approach to external audits and the implementation of Standard Operating Procedures (SOPs) that enhance operational efficiency. Furthermore, his cross-cultural communication skills enable him to effectively collaborate with diverse teams, fostering a culture of compliance and quality across the organization.
With a Global Regulatory Affairs Certification under his belt, Atsushi remains at the forefront of industry standards, particularly in the context of ICH-Q10 guidelines. His leadership in regulatory affairs not only ensures the integrity of study reports but also contributes to the overall success of pharmaceutical products in the marketplace, reinforcing his position as a key player in advancing healthcare solutions.
