Senior Director, Regulatory Affairs

The Senior Director, Regulatory Affairs position provides regulatory oversight for multiple projects focused on non-clinical and clinical aspects of drug development and associated regulations. This leadership role collaborates within Regulatory as well as with functional counterparts to ensure a global regulatory strategy is created and executed for all assigned projects. The role will also align with senior leadership on each proposed project regulatory strategy. This position is responsible for developing and implementing regulatory strategies for assigned products based on regulations, guidance, precedents and regulatory landscape, include but not limited to, developing relationships with the FDA contacts, leading FDA engagement strategies and execution, leading submissions to the INDs and BLA, tracking commitments and submission requirements. This role will partner with cross-functional subject matter experts to develop a CCDS / country label prior to Phase 3 to support the path to registration and partner with functional leads to drive development of (s)BLA strategy for registration of assigned programs. Coordinate submission requirements and regulatory engagement strategies in collaboration with external resources. Additional responsibilities related to strategic initiatives, due diligence, and policy development will be assigned on an as needed basis.