Senior Vice President, Global Regulatory Affairs & Quality
Denali Therapeutics
4 months ago
Remote friendly (South San Francisco, CA)
United States
Corporate Functions
Key Accountabilities / Core Job Responsibilities
- Establish and execute global regulatory affairs and quality strategies to 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 to ensure consistent compliance, product quality, and patient safety.
- Maintain organizational inspection readiness; oversee regulatory inspections, audits, compliance assessments, and remediation.
- Partner with Research, Development, Technical Operations, Manufacturing, Medical Affairs, Pharmacovigilance, Commercial, and Supply Chain 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 for regulatory, compliance, and quality risks.
- Drive continuous improvement, digital transformation, and data-driven quality initiatives.
- Develop and lead a high-performing global organization via workforce planning, succession management, leadership development, and talent acquisition.
- Advise executive leadership and the Board on regulatory strategy, quality performance, compliance risks, inspection outcomes, and industry trends.
Required Qualifications / Skills
- Bachelor’s degree in scientific, engineering, healthcare, or related discipline (advanced degree preferred).
- 20+ years progressive biotech/pharma/life sciences experience with significant executive leadership in Regulatory Affairs/Quality.
- Demonstrated success leading global regulatory strategy and quality organizations for development and commercial products across multiple regions.
- Extensive experience with major health authorities (e.g., FDA, EMA, PMDA, MHRA).
- Deep expertise in global regulatory frameworks, GxP, quality systems, inspection management, and enterprise compliance.
- Proven ability to lead large global organizations and influence enterprise strategy.
- Exceptional executive communication, stakeholder management, leadership, and decision-making.
Preferred
- Experience with global commercial product portfolios across multiple therapeutic areas.
- Experience leading enterprise digital quality, regulatory intelligence, or compliance transformation initiatives.
- Prior participation in executive leadership supporting public-company governance and Board interactions.
Benefits / Application Instructions
- Salary range: $422,000.00 to $440,000.00.
- Denali offers a total rewards package including 401(k), healthcare coverage, and ESPP.
- Learn more: https://www.denalitherapeutics.com/careers
- Establish and execute global regulatory affairs and quality strategies to 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 to ensure consistent compliance, product quality, and patient safety.
- Maintain organizational inspection readiness; oversee regulatory inspections, audits, compliance assessments, and remediation.
- Partner with Research, Development, Technical Operations, Manufacturing, Medical Affairs, Pharmacovigilance, Commercial, and Supply Chain 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 for regulatory, compliance, and quality risks.
- Drive continuous improvement, digital transformation, and data-driven quality initiatives.
- Develop and lead a high-performing global organization via workforce planning, succession management, leadership development, and talent acquisition.
- Advise executive leadership and the Board on regulatory strategy, quality performance, compliance risks, inspection outcomes, and industry trends.
Required Qualifications / Skills
- Bachelor’s degree in scientific, engineering, healthcare, or related discipline (advanced degree preferred).
- 20+ years progressive biotech/pharma/life sciences experience with significant executive leadership in Regulatory Affairs/Quality.
- Demonstrated success leading global regulatory strategy and quality organizations for development and commercial products across multiple regions.
- Extensive experience with major health authorities (e.g., FDA, EMA, PMDA, MHRA).
- Deep expertise in global regulatory frameworks, GxP, quality systems, inspection management, and enterprise compliance.
- Proven ability to lead large global organizations and influence enterprise strategy.
- Exceptional executive communication, stakeholder management, leadership, and decision-making.
Preferred
- Experience with global commercial product portfolios across multiple therapeutic areas.
- Experience leading enterprise digital quality, regulatory intelligence, or compliance transformation initiatives.
- Prior participation in executive leadership supporting public-company governance and Board interactions.
Benefits / Application Instructions
- Salary range: $422,000.00 to $440,000.00.
- Denali offers a total rewards package including 401(k), healthcare coverage, and ESPP.
- Learn more: https://www.denalitherapeutics.com/careers