Offer summary
Qualifications:
Bachelor's degree with 4-7 years experience (or equivalent), Master's degree preferred, 6 years pharmaceutical experience with 3 years in regulatory field, Hands-on CMC authoring experience required.
Key responsabilities:
- Develop global regulatory strategies and submissions for CMC
- Manage project activities and assess regulatory risks
- Coordinate responses to Agency queries for CMC submissions
- Participate in external regulatory interactions as needed
- Contribute to CMC-related projects and initiatives