NORIHIKO KAGAWA

Managing 20 direct reports to cover regulatory strategy, compliance, labeling, CMC and non-clinical experts.

• Manages 7-10 direct reports to cover NDA submissions, PMDA meetings, CTNs, maintenance of license, package inserts, CTD publishing, CMC (-2021) etc.
• Since 2017, obtained 4 new approvals (Hep C, HIV, Rheumatoid Arthritis and COVID-19) and some other supplemental approvals (indication expansions).
• Particularly I led remdesivir (COVID-19) project to obtain abbreviated approval first in the world by managing cross-functional and cross Japan-HQ-MHLW collaboration.
• Experienced marketing authorization transfer for HIV business (from Japan Tobacco) and now managing another transfer for CAR-T.
• Gilead Japan regulatory acts as project lead in filing to NDA process. I supervised all the projects sometimes by hands-on style. Making reasonably aggressive regulatory strategy.
• Currently focused TA is oncology (breast and lung) and CAR-T.
• As a country RA head, periodically participate global initiatives to improve process. Digests important local regulatory trend and update to global leadership.
• Member of Japan leadership team and contributes general management matters for the affiliate.
• Enhanced internal communication channels, resulting in improved information flow and decision-making processes.
• Trained personnel in equipment maintenance and enforced participation in exercises focused on developing key skills.

• Immunology and oncology TA regulatory head managing several direct reports.
• Local regulatory lead for dupilumab (IL-4/13 ab; atopic dermatitis). Communicated effectively with business partner in U.S., Regeneron.
• Contributed to make consensus for Japan filing strategy with them.
• Managed diabetes projects (insulin, GLP-1 agonist) and led NDA filing or PMDA meetings successful.
• Cultivated a positive work environment that fostered employee engagement, increased retention rates, and boosted overall team morale.

• Local regulatory lead for osteoporosis and inflammation.
• Simultaneously managed several complex projects, meeting all pertinent milestones.

• People manager with up to several direct reports (2010-).
• Local regulatory lead for diabetes (insulins, GLP agonist).
• Obtained multiple NDA approvals.
• Collaborated with other group managers to develop best practices for operational efficiency across departments.

• Facilitated co-development alliance with Japanese partner, Otsuka (Parkinson's disease).

• Regulatory professional for rheumatoid arthritis, obesity, antibiotics and colon disease (1998-).
• Clinical trial monitor.