At Eisai, we're seeking a highly-motivated Associate Director to lead our Global Submission Management team. As a key member of our team, you'll be responsible for leading submission planning, preparation, and delivery, ensuring compliance with regulatory standards and optimizing processes across regions.
Requirements
- Bachelor’s degree in scientific or information technology field
- 8+ years of pharmaceutical industry regulatory experience
- 5+ years of experience with submissions management, process development, standards development and compilation of electronic major submissions required
- Proficient with U.S. and EU submission requirements
- Advance experience with the drug development process and eCTD regulatory submission standards
- Expert understanding of Project Management concepts and techniques
- Ability to lead cross-functional team, establish effective relationships with team members and work well in a cross functional team environment
- Advance experience creating timelines for the development and submission of drug filings to regulatory health authorities
- Excellent organizational skills to support multi-task and manage submission timelines in a fast-paced environment with changing priorities
Benefits
- Eisai Inc. Annual Incentive Plan
- Eisai Inc. Long Term Incentive Plan
- Company employee benefit programs
