A BDN client is looking for a Regulatory Affairs Consultant who has experience leading the process of writing Pre-IND meeting requests and packages, IND/ CTA submissions, and understanding of CMC (Module 3) requirements for IND submissions. As a member of the Project Team, he/she will work closely with Managers and the VP of Regulatory to solve challenging client questions. The consultant will also own assigned analyses and workstreams, develop and deliver components of the client engagement, and contribute to the success of each project. A Bachelor's Degree in a scientific field is preferred for this role. The client is looking for candidates with at least 2 years of experience working with FDA, EU Regulatory Authorities, and understanding of GMP and GCP regulations. Experience analyzing and designing solutions to unstructured or ambiguous challenges and problems is preferred.