Denali Therapeutics · 16 hours ago
*PLANNED Director, Regulatory Operations
South San Francisco
Full-time
Onsite
Director/Executive
$211K/yr - $259K/yr
10+ years expDenali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases. The Director of Regulatory Operations is responsible for leading the operational execution of regulatory submissions and document management activities in support of Denali’s global development programs.
BiotechnologyGeneticsHealth DiagnosticsTherapeutics
Responsibilities
Develops and executes on a resource plan (using both internal and external resources) to support medical writing and editing efforts for all Denali-developed regulatory documents
Manages and continuously improves Denali’s regulatory document development process
Supports Development authors to ensure efficient development of high-quality regulatory documents while meeting agreed-to document development timelines
Manages Smartsheet environment and templated timelines for regulatory documents including reports and dashboards
Establishes and maintains cross-functional relationships in support of program goals; persuades and influences both internal and external stakeholders
Identifies the need for and leads non-program initiatives and activities
Supports development and maintenance of regulatory document templates and style guide(s)
Maintains up-to-date knowledge of the regulations and guidelines related to regulatory document structure and content as well as GxP quality standards
Participates in relevant industry groups
Qualification
Required
BS or BA in science/technology or an equivalent combination of education and experience
10+ years of relevant work experience required, including 7+ years of medical writing
Strong working knowledge of regulatory document development standards and best practices
Advanced skills in the use of MS Word and Smartsheet; experience working in SharePoint and Veeva RIM
Excellent communication skills and effective in a collaborative team environment
Ability to work independently and to be innovative in tackling operational challenges
Benefits
401k
Healthcare coverage
ESPP
A broad range of other benefits
Company
Denali Therapeutics
Denali Therapeutics is dedicated to defeating neurodegenerative diseases to deliver safe and effective medicines to patients and families.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.32BKey Investors
Royalty PharmaBaillie Gifford
2025-12-04Post Ipo Debt· $200M
2024-02-27Post Ipo Equity· $500M
2022-10-19Post Ipo Equity· $275M
Leadership Team
Ryan Watts
CEO
Peter Chin
Sr. Vice President & Head of Late-Stage Clinical Development and Medical Affairs
Recent News
2026-01-11
Longevity.Technology
2026-01-03
Company data provided by crunchbase