We are working on a Manager of Regulatory Affairs position for a privately held company located in northern NJ. The position is part of their drug and device group focusing specifically on the drug side.
They have both NDA and OTC product lines and this position is supporting the NDA products. Their pipeline is very active and they do have several submissions coming up that will require both R&D and clinical work as well as dealing directly with the FDA.
This position is a solo contributor role, but is the most senior level position on the team.
The challenge is to find someone with the following experience:
Knows the pharma side of Regulatory (IND, NDA docs and processes).
Good at managing multiple projects.
Sat with R&D teams and provided guidance.
Worked with the FDA - this is Manager level.
Worked with eCTD – electronic documents and submissions.
This is a medium sized company with a very flat organization with no big politics or hierarchy. They thrive in an open, supportive, team oriented culture.