Function Lead, International Regulatory; Exec Director​/Sr. Director

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. The Function Lead, International Regulatory, is a highly motivated and strategic regulatory professional with global expertise in drug development and regulatory submissions. This individual will be accountable for leading and executing Denali’s international regulatory strategy across a portfolio of development-stage and commercial neuroscience programs.

This leader is responsible for ensuring successful interactions with Health Authorities outside the U.S., including the EMA, PMDA, and other key global agencies. The role will oversee a team of international regulatory professionals and will partner cross-functionally to ensure regionally appropriate strategies, risk mitigation plans, and regulatory compliance. Denali is seeking candidates with a global mindset, strong technical and operational regulatory acumen, and a passion for advancing therapies that can change the lives of patients with neurodegenerative diseases.

Developing and implementing international regulatory strategies for clinical development and commercial-stage products across Denali’s global portfolio Leading the planning, preparation, and submission of regulatory applications including Clinical Trial Applications (CTAs), Marketing Authorization Applications (MAAs), Orphan Drug Designations, and other key filings to Health Authorities outside the United States Serving as the primary liaison with global Health Authorities (e.g., EMA, MHRA, PMDA, Health Canada), including leading preparation for and participation in scientific advice meetings and regulatory interactions Collaborating with cross-functional teams to support timely initiation and maintenance of global clinical trials and product registrations Monitoring global regulatory developments, assessing impact on programs, and translating requirements into clear regulatory strategies and recommendations Ensuring the quality, consistency, and compliance of international regulatory submissions and communications Leading the development and maintenance of internal processes and tools for global regulatory activities, including policies, templates, and training initiatives Partnering with regional affiliates, CROs, and local consultants to execute submissions and maintain compliance with local requirements Supporting global labeling strategies and alignment with U.S. labeling, where applicable Mentoring, developing, and managing international regulatory team members, and fostering a culture of collaboration, innovation, and excellence Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement.

Bachelor’s degree required; advanced degree in life sciences or related discipline strongly preferred 12+ years of regulatory affairs experience in the pharmaceutical or biotechnology industry, with at least 8+ years in international regulatory affairs Direct experience with major international regulatory agencies (e.g., EMA, PMDA, Health Canada, TGA, Swiss medic) Demonstrated success in leading global submissions, including CTAs and MAAs, and in developing international regulatory strategies for early- to late-stage development programs Thorough knowledge of international regulatory frameworks, including ICH guidelines, EU directives, and regional requirements Strong leadership, decision-making, and project management skills, with a demonstrated ability to drive strategic outcomes across global teams Excellent written and verbal communication and influencing skills, including experience interacting with senior leadership and global regulators Experience managing and mentoring regulatory professionals Ability to navigate complex…