18478 RA Manager
・Manage a robust and established team of nearly 10 employees.
・Develop an effective regulatory strategy for each project from a broad perspective and achieve active product introduction.
・Develop logical thinking, simplify complex information and provide logical explanation.
・Proactively advance each project with skills to deliver powerful, compelling messages while maintaining good communication with various parties at the company, MHLW/PMDA and industries.
・Understand PMDA/MHLW’s thinking and successfully negotiate for the benefit of the company and projects.
・Enhance internal compliance and risk management system based on understanding of the Japanese PMD Act and other business-related laws and regulations.
・2-3 years of people-management experience
・Strong interpersonal skills required in the areas of verbal and written communications, focus on regulatory bodies, appropriately responsive to service to internal business needs, coaching, influencing, and team building with growth mindset.
・Strong listening and assessment skills.
・Strong questioning & problem-solving skills.
・Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities.