This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Regulatory Affairs based in United States. This is a senior regulatory leadership opportunity supporting the development of life-changing therapies from early clinical development through NDA/BLA submission. You’ll provide strategic and operational regulatory guidance to pharmaceutical, biotechnology, and clinical research clients. The role combines hands-on regulatory writing, scientific expertise, client leadership, and direct engagement with health authorities. You’ll serve as a trusted advisor to clients while leading complex regulatory development programs across clinical phases. You’ll collaborate with cross-functional scientific teams and act as a key point of contact with agencies such as the FDA. The position also offers opportunities to contribute to business development, marketing, and the continued growth of a global regulatory consulting practice. This is a fully remote role in a collaborative, international environment focused on accelerating therapies to patients.