Job Summary
A biotechnology company has an open position for a Remote Pharmaceutical Regulatory Affairs Director.
Candidates will be responsible for the following:
- Being the key contact for FDA on product(s) and with direct FDA interaction
- Driving the US product labeling
- Providing mentorship to junior regulatory staff
Skills and Requirements Include:
- 8+ years’ experience in the pharmaceutical industry within R&D, Regulatory or a related function
- 5 years working in regulatory affairs
- Experience working with the FDA (ideally both with CBER and CDER)