Related skills
regulatory nda ema fda cmc📋 Description
- Regulatory strategy and submissions for projects
- Coordinate with cross-functional teams (SC, QA, CMOs)
- Prepare regulatory submissions, licenses, annual updates
- Lead Health Authority interactions (FDA/EMA)
- Manage submissions (IND/CTA, BLA/NDA/MAA)
- Travel up to 5-10%
🎯 Requirements
- Bachelor's degree in science + 8+ years regulatory experience; advanced degree preferred
- Strong global drug development knowledge (US/EU) in early and late-stage
- Regulatory policy knowledge and submissions writing proficiency
- Experience interacting with FDA or EMA
- Excellent written and verbal communication across disciplines
- US and ex-US submissions experience (IND/CTA, BLA/NDA/MAA)
🎁 Benefits
- Remote work opportunities within the United States
- Travel to Cambridge, MA several times a year
- Inclusive, Equal Opportunity Employer culture
- Competitive compensation (non-salary perks)
Meet JobCopilot: Your Personal AI Job Hunter
Automatically Apply to All Other Jobs. Just set your
preferences and Job Copilot will do the rest — finding, filtering, and applying while you focus on what matters.
Help us maintain the quality of jobs posted on Empllo!
Is this position not a remote job?
Let us know!