Required SkillsPropose and design well-informed regulatory strategies for the US and EURepresent Regulatory Affairs on project subteams, especially Clinical and Nonclinical, and provide regulatory guidance to project teams (e.g., protocol reviews, report reviews, development plans)Assist in the preparation for regulatory agency meetings (e.g., Pre-IND, End-of-Phase 2, Type C, Pre-NDA/MAA/NDS)Lead the preparation of regulatory submissions including INDs, CTAs, annual reports, NDAs, MAAs,....