The consultant will serve as a resource to LDT members for the regulatory requirements, processes, and logistics to conduct drug development activities for small molecule compounds from the preclinical stage through to the initial clinical stage. The consultant may be asked to provide strategic guidance for chemical manufacturing and controls (CMC) regulatory activities necessary to enable preclinical drug product manufacturing, IND enabling studies, and clinical trials. The role of the CMC/Pharmaceutics consultant may include but is not limited to the following responsibilities and tasks: • Lead CMC activities for compounds in development, in accordance with the US regulatory and the ICH guidelines. • Provide expertise in drug substance manufacturing, analytical method development, and process development for small molecules. • Provide pharmaceutical sciences leadership in chemical manufacturing, formulation, and product development for small molecules. • Provide CMC guidance and strategy to LDTs, including identifying and assessing regulatory risks. • Ensure the timely preparation, review and submission of CMC documents to regulatory authorities including FDA, EMA and other national authorities, to support the conduct of clinical trials and marketing applications. • Ensure the compliance of CMC activities with applicable regulatory requirements. • Evaluate manufacturing processes and changes, assess regulatory implications and support process implementation. • Assist NIH with inspections and onsite visits with contract organizations. • Maintain current knowledge of the relevant guidelines and regulations and determine applicability to activities. • Provide expertise in dose form selection. • Provide expertise in API development and related activities.