The Sr. Manager will focus on regulatory activities for our client's late stage vaccine product and will support early stage (Pre-IND) products, as necessary. This person will serve as a regulatory representative on Product Development Teams and provide CMC regulatory strategy and guidance for a Phase 3 product in preparation for a BLA. They will provide authoring, review, and coordination for quality submissions to regulatory agencies. They will also prepare for meetings, teleconferences, and other communications (including pre-read packages and/or other necessary documentation) with FDA. They will educate teams regarding regulatory risks and implications for strategy and product development activities, and utilize technical knowledge and effectively apply regulations and guidelines to the product development process.