Help us change livesAt Exact Sciences, we're helpingchange how the world prevents, detects and guides treatment for cancer.We give patients and clinicians the clarity needed to make confident decisions when they matter most.Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to supportyourlife while you're working to help others.Position OverviewThe Lead Regulatory Affairs Manager, International will support or lead the creation and submission of product Technical Files/Standard Technical Documentation and other submission related documents for market authorizations in targeted markets and countries.The Lead Regulatory Affairs Manager, International supports or leads the creation and execution of regulatory strategy for assigned projects, including new product development, product changes, and manufacturing improvement initiatives.This role assists in creating, developing, and implementing global regulatory affairs procedures and educating others on global regulatory expectations and requirements.Essential DutiesInclude but are not limited to the following:Participate, lead or support the preparation and maintenance of regulatory submissions and other premarket registrations to acquire appropriate commercial distribution approvals and/or clearances.Support or lead as needed regulatory strategy development, document appropriate regulatory strategy for proposed new products and markets and initiate necessary activities by working with project teams and regulatory team members as needed.Control and maintain regulatory records.Represent Regulatory Affairs on project teams by attending team meetings and providing the required plans, procedures and regulatory decisions.Manage distributors and RA consultants to ensure global registrations are completed on time and maintained.Review and approve documents and product changes for regulatory compliance, determining if a new premarket application is required.Review technical publications, ar