Fast-Track is seeking a Director of Regulatory Affairs who has experience in drug and biologic clinical development and regulatory strategic planning and strong writing skills for the development of regulatory documents including preIND, IND, and NDA/BLA for US FDA submissions. The individual we are seeking must be able to leverage their regulatory and clinical knowledge and experience to ultimately contribute to the growth and success of Fast-Track Drugs & Biologics, LLC and the successful licensure of important drugs and biologics. Key Duties and Responsibilities Manage and interface with Clients on strategic planning on all phases of drug or biologic development from nonclinical development to support IND and clinical development from Phase 1 thro