Senior Vice President, Global Regulatory Affairs & Quality

4w1 month ago

Denali Therapeutics

South San Francisco, US · Full-time · $422,000 – $440,000

About this role

Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases, one of the largest medical challenges of our time. This role provides enterprise leadership for global regulatory affairs and quality across the product lifecycle, ensuring the delivery of innovative therapies with the highest standards of compliance and patient safety.

Day-to-day responsibilities include shaping long-term regulatory and quality strategies that support development, commercialization, and lifecycle management. The SVP leads regulatory engagement with global health authorities to advance approvals and influence evolving frameworks, while directing enterprise quality systems and inspection readiness across GxP operations.

As a key member of the executive leadership team, this role partners with Research, Development, Manufacturing, Medical Affairs, and Commercial leaders to drive business performance. It builds a culture of quality, accountability, and continuous improvement across a global organization, overseeing regulatory submissions, labeling strategies, and post-approval commitments.

This position offers the opportunity to shape the regulatory and quality direction of a pioneering biotechnology company. It involves developing a high-performing global organization through strategic workforce planning and leadership development, and advising the Board of Directors on regulatory strategy and emerging industry trends.

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 ability to lead global regulatory and quality organizations, with deep knowledge of GxP requirements and health authority interactions.
Proven experience developing and executing regulatory strategies for innovative therapies, including interactions with FDA, EMA, and other global agencies.
Strong understanding of quality systems, compliance management, and inspection readiness across the product lifecycle.
Executive-level leadership skills, including strategic workforce planning, talent development, and building a culture of accountability and continuous improvement.
Excellent judgment and decision-making ability in assessing regulatory opportunities, quality performance, and enterprise risk.

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 cross-functional leaders across Research, Development, Technical Operations, Manufacturing, Medical Affairs, Pharmacovigilance, Commercial, and Supply Chain.
Oversee regulatory submissions, product registrations, labeling strategies, post-approval commitments, and lifecycle management activities across global markets.
Establish enterprise risk management processes to identify, assess, and mitigate regulatory, compliance, and quality risks.
Advise executive leadership and the Board of Directors on regulatory strategy, quality performance, compliance risks, and emerging industry trends.