Offer summary
Qualifications:
Bachelor's degree or Master's degree, 3-5 years relevant experience or 1-2 years for Master's, Working knowledge of regulatory CMC submissions, Experience in Cell Therapy is a plus, Excellent organizational skills.
Key responsabilities:
- Manage documentation activities for regulatory submissions
- Coordinate reviews and facilitate consensus meetings
- Ensure use of correct formatting for submissions
- Participate in cross-functional project teams
- Verify submission data accuracy