In this role, you would have the opportunity to work with a clinical stage bio-pharmaceutical company focused on the development of products aimed to treat a broad range of rare diseases! They are looking for a candidate with both hands-on technical experience as well as management experience. This is a newly created position due to company expansion and one product currently in Phase III of clinical trials, so now is an exciting time to join!
- Provide strategic oversight and risk assessment for designated products
Oversees and reviews sections of IND/CTA, NDA and other global submissions documentation
Establishes themselves as a point of contact for global regulatory agencies
Prepare and manage submission documentation