Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects
Job Summary
Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects.
Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible.
This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.
Matching Summary
Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects.
Salary
Base: $154,400.00 - $242,550.00; Bonus/Equity: Not specified; Benefits: Medical, dental, vision, 401(k) plan and company match, disability coverage, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, sick time, vacation
Skills & Requirements
Must-have
Global regulatory strategy development
Lead Global Regulatory Teams
US FDA submissions and approvals
Health authority interactions
Regulatory compliance oversight
Nice-to-have
Cross-functional initiative leadership
Influencing the field
Vendor management
Due diligence for licensing
Key Requirements
6+ years pharmaceutical industry experience
4+ years regulatory experience
Bachelor’s Degree in scientific discipline
Advanced degree in scientific discipline preferred