The Company is seeking an Executive Director of Regulatory Strategy to take on a pivotal role as the regulatory face of its lead program, which is in the registration stage and operates in a dynamic and competitive market. The successful candidate will be responsible for leading the regulatory strategy, solving complex regulatory challenges, and building and expanding the regulatory organization to support various global submissions. This is a unique opportunity to shape the team and its operations, particularly in the context of NDA, MAA, and other international regulatory processes. Applicants for the Executive Director of Regulatory Strategy position at the company should have a proven track record in regulatory affairs, with a focus on clinical-stage assets. The role requires a strategic thinker who can navigate the intricacies of the regulatory landscape and is adept at problem-solving in a fast-paced environment. Experience in leading and expanding a regulatory team, as well as a deep understanding of global regulatory submissions, is essential. The ideal candidate will be a visionary leader, capable of driving the regulatory function forward and ensuring the successful development and approval of innovative, transformational medicines.