Senior Manager, Regulatory Operations (Remote Eligible)

Denali Therapeutics•South San Francisco, CA

1d•Remote

About The Position

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.

Requirements

Typically requires a Bachelor’s degree in a scientific, technical, or related field and 10+ years of regulatory operations experience with progressive responsibility and complex global submissions.
Deep knowledge of global regulatory submission standards (e.g., US, EU, eCTD)
Advanced proficiency with publishing tools and RIM platforms
Demonstrated ability to independently manage complex deliverables and competing priorities
Strong cross-functional collaboration and influencing skills without direct authority
Proven ability to identify process gaps and implement improvements

Responsibilities

Lead end-to-end publishing and submission activities for regulatory filings across programs
Independently manage complex timelines, priorities, and deliverables across multiple stakeholders
Ensure production of high-quality, compliant regulatory documents and submissions (eCTD and related formats)
Partner with Clinical and CMC Regulatory, Medical Writing, and functional teams to align on submission strategy and execution
Identify and resolve operational issues; provide expert guidance on tools, formats, and submission requirements
Drive improvements to regulatory operations processes, standards, and templates
Provide support and training to end users of RIM systems and other tools supporting document development, publishing, and submissions
Provide technical expertise and troubleshooting support for publishing tools (e.g., Word, Adobe, submission systems)
Ensure accurate and timely archiving of regulatory records and submissions
Stay current on global regulatory publishing standards and apply insights to enhance practices