Description
We are seeking a Japan Submission Manager to lead the preparation of regulatory submissions to PMDA and MHLW for new drug and vaccine development.
The successful candidate will supervise a team of 4 members and provide leadership on global document management systems.
As a member of the leadership team, you will also contribute to department operations.
Key Responsibilities:
- Manage project documentation for regulatory submissions
- Supervise team members
- Lead implementation and operation of global document management systems
- Collaborate with cross-functional teams
Requirements:
- Understanding and experience in pharmaceutical development
- Ability to work cross-functionally
- Leadership and mentoring skills
- Fluent Japanese and business-level English
Preferred Qualifications:
- Experience in global pharmaceutical companies
- Knowledge of regulatory document systems
- Experience in matrix organization management
What We Offer:
- Opportunity to work with a global biopharma company
- Collaborative and dynamic work environment
- Flexible working arrangements