Interim RA CMC Manager
IND Regulatory Affairs SME
Our client is a large biotechnology and pharmaceutical company who is currently working on a nasal spray product. They are looking for someone to come on board and help prepare their IND and Pre-IND filings.
The consultant will be coming on board to run the submission of the companies IND. The consultant who is chosen for this role must be a SME in filing IND' s to the FDA and have had multiple successful filings. In addition to IND' s, this person must be well versed in Clinical CMC in a pharmaceutical background. This person will be acting as the lead for this project and must be comfortable working with little to no direction.
- CMC background
- Vaccine product Group experience
- IND development experience