Associate Director, Regulatory Project Manager
Denali Therapeutics
August 10, 2026
Remote friendly (South San Francisco, CA)
United States
Corporate Functions
Key Accountabilities / Core Job Responsibilities
- Lead development and management of regulatory activity timelines across the portfolio, including regulatory documents, health authority interactions, and submissions; anticipate downstream risk and adjust strategy as priorities shift.
- Partner with Regulatory Program Managers and Program Directors to align regulatory timelines with corporate and program-level goals; resolve competing priorities.
- Manage external partnerships with vendors.
- Drive timely delivery from cross-functional SMEs; unblock complex, ambiguous issues without a standard playbook.
- Support cross-functional health authority interaction and filing team project needs; own risk identification, mitigation planning, and timeline impact assessment with Filing Team/Health Authority Interaction Leads.
- Own regulatory timeline templates and resourcing models; shape Regulatory Affairs long-range and annual budget forecasting.
- Drive regulatory initiatives and/or represent Regulatory Affairs on strategic cross-functional initiatives.
- Mentor and provide technical direction to junior regulatory project management staff on complex filings (no formal supervisory responsibility).
Qualifications / Skills
- Typically requires: 12+ years related experience with Bachelor’s; or 10+ years with Master’s; or PhD with 7+ years; plus 5+ years project/program management experience.
- Demonstrated experience leading regulatory project management across INDs/CTAs and marketing applications; rare disease and/or complex filing preferred.
- Proficiency in Smartsheet or comparable project/resource management software.
- Ability to lead cross-functional teams and influence senior stakeholders without direct authority.
- Strong track record proactively identifying and resolving ambiguous, multi-stakeholder risks.
Benefits
- 401k, healthcare coverage, ESPP, and other benefits (competitive total rewards package).
Application
- Learn more at https://www.denalitherapeutics.com/careers
- Lead development and management of regulatory activity timelines across the portfolio, including regulatory documents, health authority interactions, and submissions; anticipate downstream risk and adjust strategy as priorities shift.
- Partner with Regulatory Program Managers and Program Directors to align regulatory timelines with corporate and program-level goals; resolve competing priorities.
- Manage external partnerships with vendors.
- Drive timely delivery from cross-functional SMEs; unblock complex, ambiguous issues without a standard playbook.
- Support cross-functional health authority interaction and filing team project needs; own risk identification, mitigation planning, and timeline impact assessment with Filing Team/Health Authority Interaction Leads.
- Own regulatory timeline templates and resourcing models; shape Regulatory Affairs long-range and annual budget forecasting.
- Drive regulatory initiatives and/or represent Regulatory Affairs on strategic cross-functional initiatives.
- Mentor and provide technical direction to junior regulatory project management staff on complex filings (no formal supervisory responsibility).
Qualifications / Skills
- Typically requires: 12+ years related experience with Bachelor’s; or 10+ years with Master’s; or PhD with 7+ years; plus 5+ years project/program management experience.
- Demonstrated experience leading regulatory project management across INDs/CTAs and marketing applications; rare disease and/or complex filing preferred.
- Proficiency in Smartsheet or comparable project/resource management software.
- Ability to lead cross-functional teams and influence senior stakeholders without direct authority.
- Strong track record proactively identifying and resolving ambiguous, multi-stakeholder risks.
Benefits
- 401k, healthcare coverage, ESPP, and other benefits (competitive total rewards package).
Application
- Learn more at https://www.denalitherapeutics.com/careers