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.

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 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

Qualifications/Skills:

• 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

Salary Range: $155,000.00 to $202,000.00 .  Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.
 

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.