Project Closed

Regulatory Affairs Consultant- full time 6 months (at least)

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