Preferred: Demonstrated experience preparing and managing INDs and/or IDEs; familiarity with companion diagnostics and combination products is a plus, and an in-depth knowledge of FDA regulations, FDA submissions, ICH guidelines, and GCP requirements, and an experience with EMA submissions. The ideal candidate brings a preferred Master's degree in a life sciences, pharmacy, medicine, or related field, along with extensive experience in oncology regulatory affairs, including IND and IDE submissions, FDA interactions, FDA submissions and EMA exposure.