Regulatory Strategy Director, Clinical Programs

Denali Therapeutics; South San Francisco (CA); On-site; USD 211,000 - 258,667; Full time

Benefits offered by this job

401k

Healthcare coverage

Employee Stock Purchase Plan (ESPP)

Job summary

Denali Therapeutics, located in South San Francisco, is looking for an experienced professional to develop regulatory strategies for complex programs.

The role requires 10+ years of experience in regulatory affairs, leadership in cross-functional teams, and expertise in drug development processes. Benefits include a competitive salary range of $211,000 to $258,667, healthcare coverage, and a 401k plan.

Qualifications

• Bachelor’s degree required; advanced degree in life sciences strongly preferred.
• 10+ years of relevant work experience required, including 8+ years in regulatory affairs.
• Thorough working knowledge of drug development process and regulatory requirements.

Responsibilities

• Develop regulatory strategy for complex development programs.
• Participate in cross-functional teams for regulatory feedback.
• Oversee global Health Authority interactions and submissions.
• Lead and manage regulatory teams, ensuring compliance.

Skills

Regulatory strategy development

Team leadership

Drug development knowledge

Strategic thinking

Collaboration skills

Communication skills

Education

Bachelor’s degree

Advanced degree in life sciences

Job description

Denali Therapeutics, located in South San Francisco, is looking for an experienced professional to develop regulatory strategies for complex programs.

The role requires 10+ years of experience in regulatory affairs, leadership in cross-functional teams, and expertise in drug development processes. Benefits include a competitive salary range of $211,000 to $258,667, healthcare coverage, and a 401k plan.