Our client is looking for an AD Regulatory CMC Consultant to assist and lead product in early development stages within oncology, rare disease and vaccines. Daily Responsibilities will include IND activities, support to project teams, meeting with health agencies and writing briefing books. The client also needs ongoing cancer vaccine support from each ranking individual. The current VP has a strong scientific background, but needs support of the directors and manager. Specifically he needs the AD/Director to structure the science into regulatory language and manager day-to-day operational work and IND amendments. Client now preparing for phase 3 in August. Oncology experience would be helpful. CBER – gene therapy, advanced cell therapy, biologics experience critical. Global experience is a big plus.
Regulatory Affairs CMC, IND, Biologics
• Gene & Cell Therapy (HUGE PLUS)
• Global Experience (EU, Australia, Japan, etc.)
• Medical Devices (Client is using part of program for bioinformatics algorithm to design which antigens will be included)
• Advanced degree is preferable, but not required if they understand the science. especially for the director level. Don’t want to rule out experts without advanced degrees.
Remote: AD Reg CMC Consultant (233210)