Senior Manager, Regulatory Operations (Remote Eligible)
Denali Therapeutics · South San Francisco, California, US
Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing brea...
Job description
Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. Drives end-to-end regulatory publishing and submission operations to enable global regulatory filings. Ensures high-quality, compliant outputs while independently managing complex timelines and cross-functional coordination. Applies deep expertise in regulatory systems and processes to solve operational challenges and improve efficiency. Influences ways of working across development teams to support consistent and scalable execution. Key Accountabilities/Core Job Responsibilities: Lead end-to-end publishing and submis...