This role involves independently developing regulatory CMC strategies and leading the execution of investigational, registration, and post-approval strategies for assigned products
Job Summary
This role involves independently developing regulatory CMC strategies and leading the execution of investigational, registration, and post-approval strategies for assigned products.
The successful candidate will represent Takeda in Health Authority meetings and drive preparation activities to ensure regulatory success throughout the product lifecycle.
Takeda offers a hybrid work environment with competitive compensation, comprehensive benefits including medical and dental insurance, and opportunities for professional growth.
Matching Summary
This role involves independently developing regulatory CMC strategies and leading the execution of investigational, registration, and post-approval strategies for assigned products.
Salary
Base: $177,000.00 - $278,080.00; Bonus/Equity: Short-term and/or long-term incentives eligible; Benefits: Medical, dental, vision, 401(k) match, paid time off
Skills & Requirements
Must-have
Global Regulatory Affairs CMC strategy
Leading major registrational submissions
Health Authority negotiations
Complex drug product experience
Regulatory compliance oversight
Nice-to-have
Mentoring GRA CMC team members
Cross-functional collaboration skills
Inclusive culture promotion
Strategic change control evaluation
Key Requirements
BS/BA Degree required with Advanced Degree (MS/PhD)