My client is Gene Therapy Bio-tech focused in rare diseases with science designed to use lentiviral vectors to integrate therapeutic genes into the patient's own stem cells. They are looking for an Associate Director of Regulatory Affairs who will manage and maintain regulatory submissions providing support to the head of regulatory. You will be responsible for maintenance of IND related activities while participating in cross functional studies to support clinical trial applications and provide regulatory guidance as needed. You will assist in developing the implementation of regulatory strategies for program development and serve as a backup liaison with regulatory agencies.
Excellent operational skills including planning, organizing and the ability to motivate others