This individual will partner closely with Technical Operations, Process Chemistry, Analytical Development, Formulation, Manufacturing, Quality, Clinical, Nonclinical, Regulatory Operations, and external partners, and will support interactions with the US FDA and other global health authorities as appropriate. Monitor global CMC regulations, identify CMC regulatory risks, gaps, and dependencies; develop mitigation strategies and communicate collected intelligence, precedence and potential impacts on program timelines, submission plans, and product development decisions.