Northeast US based drug sponsor in need of Regulatory Affairs consultant. There is a Head of Regulatory at present but is overloaded, needs an experienced second pair of hands to jump in and start adding value in the some of the following areas-
- Reg strategy, labeling, FDA required updates, interacting with partners, etc. to support about 6 NDAs
- Want someone with both IND and post-marketing experience, and with branded drug experience
- Looking for more of a generalist (e.g., not a CMC person specifically)
- US-based, virtual
- Full-time role for at least 6 months