Senior Regulatory Project Leader – IND/CTA Submissions

Denali Therapeutics Inc; South San Francisco (CA); On-site; USD 171,000 - 223,000; Full time

Benefits offered by this job

401k

Healthcare coverage

ESPP

Other benefits

Job summary

Denali Therapeutics Inc is seeking an experienced Regulatory Project Manager to drive the regulatory strategy and timelines across a portfolio of neurodegenerative disease programs. You will partner with Regulatory Affairs, Medical Writing, Operations, and development SMEs to ensure submissions stay on track and aligned with program goals.

The role emphasizes proactive risk identification, cross-functional collaboration, and timely vendor coordination, with mentorship of junior staff and support

Qualifications

• Requires a strong background in regulatory project management across INDs/CTAs and marketing applications.
• Experience leading cross-functional teams and influencing senior stakeholders.
• Proven ability to identify risk proactively and drive resolution in complex programs.
• Proficiency with project management tools and documentation standards.

Responsibilities

• Lead development and management of regulatory activity timelines across the portfolio.
• Partner with program managers to align regulatory timelines with corporate goals.
• Manage external partnerships with vendors.
• Unblock complex issues and ensure timely regulatory submissions.
• Support health authority interactions and filing team needs, including risk assessment.
• Own regulatory timeline templates and resourcing models; contribute to budget forecasting.
• Drive regulatory initiatives and participate in cross-functional programs.
• Mentor junior regulatory project management staff.

Skills

Regulatory project management

Cross-functional leadership

Risk identification

Timeline management

Vendor management

Regulatory submissions

INDs/CTAs filings

Smartsheet

Education

Bachelor's degree

Master's degree

PhD

Tools

Smartsheet

Job description

Denali Therapeutics Inc is seeking an experienced Regulatory Project Manager to drive the regulatory strategy and timelines across a portfolio of neurodegenerative disease programs. You will partner with Regulatory Affairs, Medical Writing, Operations, and development SMEs to ensure submissions stay on track and aligned with program goals.

The role emphasizes proactive risk identification, cross-functional collaboration, and timely vendor coordination, with mentorship of junior staff and support