Senior Vice President, Global Regulatory Affairs & Quality

Denali Therapeutics•South San Francisco, CA

7d•$422,000 - $440,000

About The Position

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. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. Provides enterprise leadership for global regulatory affairs and quality across the product lifecycle, ensuring the organization delivers innovative therapies while maintaining the highest standards of compliance, product quality, patient safety, and regulatory excellence. Shapes long-term regulatory and quality strategies that support development, commercialization, lifecycle management, geographic expansion, and sustainable business growth. Serves as a key member of the executive leadership team, influencing critical business decisions through expert assessment of regulatory opportunities, quality performance, and enterprise risk. Builds a culture of quality, accountability, and continuous improvement across a global organization.

Requirements

Typically requires a Bachelor's degree in a scientific, engineering, healthcare, or related discipline; advanced degree preferred.
Typically requires 20+ years of progressive biotechnology, pharmaceutical, or life sciences industry experience, including significant executive leadership responsibility within Regulatory Affairs, Quality, or related disciplines.
Demonstrated success leading global regulatory strategy and quality organizations supporting both development-stage and commercial products across multiple regions.
Extensive experience interacting with major health authorities, including FDA, EMA, PMDA, MHRA, and other international regulatory agencies.
Deep expertise in global regulatory frameworks, GxP requirements, quality systems, inspection management, and enterprise compliance programs.
Proven ability to lead large global organizations and influence enterprise-level strategy through periods of growth, change, and organizational complexity.
Exceptional executive communication, stakeholder management, organizational leadership, and decision-making capabilities.

Nice To Haves

Supporting global commercial product portfolios across multiple therapeutic areas.
Leading enterprise digital quality, regulatory intelligence, or compliance transformation initiatives.
Prior participation in executive leadership teams supporting public-company governance and Board interactions.

Responsibilities

Establish and execute global regulatory affairs and quality strategies that support corporate objectives, product development, commercialization, and lifecycle management.
Lead regulatory engagement and advocacy with global health authorities to advance approvals, maintain product licenses, and influence evolving regulatory frameworks.
Direct enterprise quality systems and governance across GxP operations, ensuring consistent compliance, product quality, and patient safety worldwide.
Maintain organizational inspection readiness and oversee regulatory inspections, audits, compliance assessments, and remediation activities.
Partner with Research, Development, Technical Operations, Manufacturing, Medical Affairs, Pharmacovigilance, Commercial, and Supply Chain leaders to drive business performance and operational excellence.
Oversee regulatory submissions, product registrations, labeling strategies, post-approval commitments, and lifecycle management activities across global markets.
Establish enterprise risk management processes that identify, assess, and mitigate regulatory, compliance, and quality risks.
Drive continuous improvement, digital transformation, and data-driven quality initiatives that enhance efficiency, scalability, and compliance effectiveness.
Develop and lead a high-performing global organization through strategic workforce planning, succession management, leadership development, and talent acquisition.
Advise executive leadership and the Board of Directors on regulatory strategy, quality performance, compliance risks, inspection outcomes, and emerging industry trends.