Senior Vice President, Global Regulatory Affairs & Quality

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 Salary range: $422,000.00 to $440,000.00. Denali offers a total rewards package including 401(k), healthcare coverage, and ESPP. #J-18808-Ljbffr Scorpion Therapeutics