Senior Manager, Regulatory Affairs

The Regulatory Affairs (RA) Senior Manager works collaboratively with the RA Director and other cross-functional team leaders and is responsible for managing the US IND and managing the oversight of regulatory information management (RIM) systems. The role involves preparation and completion of global regulatory submissions and active management of regulatory systems throughout the product lifecycle for EFX. This role also involves projects that continuously improve or otherwise advance RA capabilities. Leads project teams and actively participates in the development and writing of high-quality regulatory documents. Independently authors regulatory documents and critically reviews documents for submission readiness to Health Authorities (HAs). Oversees the preparation, compilation, and timely completion of regulatory submissions. Enhances delivery of Akero’s regulatory objectives by building effective internal and external relationships. Manages Veeva Regulatory Information Management (RIM) and internal Akero systems. Facilitates regulatory team meetings and is responsible for effective and efficient conduct and follow-through. Contributes to the ongoing development and refinement of regulatory strategies, processes, standards, practices, efficiencies, and capabilities.