- Remote, United States
- Remote
- Senior
- 5+ years
Provide end-to-end regulatory support for pharmaceutical and biotechnology development and commercialization programs, including IND/NDA submission management, lifecycle maintenance, health authority interactions, and regulatory intelligence.
Compensation
We offer competitive compensation and a comprehensive benefits package to eligible employees, including paid time off, a 401(k) match, life insurance, health insurance, and additional benefit offerings in accordance with the terms of our applicable plans. Some roles may also be eligible for additional incentives, bonuses, or other compensation programs.
Responsibilities
- Lead or support IND and NDA submission management
- Maintain detailed tables of contents and submission trackers
- Coordinate with regulatory publishing and document management
- Draft and coordinate FDA forms and supporting documentation
- Support major regulatory submissions
Requirements
- Bachelor’s degree in a scientific, technical, or related discipline required; advanced degree preferred