・Advises global internal stakeholders and business partners on best practices regarding planning and execution of labeling strategies.
・Responsible for leading the creation, implementation and maintenance of the Company Core Data Sheets applying scientific and clinical knowledge to the process.
・Manages labeling content review and approval process applying regulatory, therapeutic area and clinical knowledge to the process.
・Collaborates to assure labeling-relevant aspects of global and local regulatory strategies reflect best in class applications and programs meet all applicable regulatory and business requirements.
・Provide oversight to other Regulatory personnel including regional leads and ROW labeling implementation leads who are responsible for developing labeling/packaging or managing labeling content and ensure consistency across product
・Working knowledge of FDA, EU, Japan, and China guidance, and labeling standards to business situations and medical and scientific content.
・Demonstrated expert proficiency in managing and control of pharmaceutical labeling in accordance with local and global regulatory requirements. Direct pharmaceutical labeling development experience required with demonstrated proficiency in managing change control.
・Communication skills to establish positive relationships with the stakeholders and vendors
・Business level Japanese and English skills to comfortably work and communicate with colleagues in a global environment (TOEIC score 750 points or higher or equivalent)
・Proven effectiveness with stakeholders in the labeling system from content development through commercial supply.
・Previous experience working with US and ex-US labeling requirements, company core data sheet (CCDS) implementation and execution, and other regulatory requirements impacting or associated with labeling.
・Must be able to effectively influence peers both inside and outside the organization and maintain
【諸手当】Discretionary work allowance, Housing allowance, Commutation allowance, etc.
【Salary Raise】Once a year
【Bonus】Twice a year (July, December)
Weekends(Sat and Sun), holidays, May 1st, summer vacation, New Year holidays
Annual paid leave, childcare leave system, nursing care leave system, etc.
【保険】Employment Insurance, Industrial Accident Compensation Insurance, Welfare Pension Insurance, Health Insurance, Mutual Aid Association System, Company Housing System, Employee Shareholder Association System,Property Accumulation Savings System
※8:30～17:30（Mon～Thu）、8:30～15:45（Fri）、Flex-time system or Discretionary Work System