Function Lead, International Regulatory (Exec Director/Sr. Director)

Denali Therapeutics Inc; Zürich; Vor Ort; CHF 180.000 - 280.000; Vollzeit

Benefits dieser Stelle

Pension plan

Medical stipend

Equity

Other benefits

Zusammenfassung

Denali Therapeutics Inc. is seeking a strategic Lead, International Regulatory to steer global regulatory strategies for neuroscience programs. You will oversee submissions to EMA, PMDA and other authorities, while partnering with cross-functional teams to ensure timely clinical and commercialization milestones.

The role requires broad regulatory expertise, a leadership mindset, and ability to mentor a team across regions, balancing regulatory requirements with company objectives.

Qualifikationen

• Bachelor's degree in life sciences or related field.
• 12+ years regulatory affairs experience with at least 8+ years in international regulatory affairs.
• Direct experience with EMA, PMDA, Health Canada, and other major agencies.
• Strong leadership, decision-making, and project management skills.
• Excellent written and verbal communication with senior leaders and regulators.

Aufgaben

• Develop and implement international regulatory strategies for clinical development and commercial products globally.
• Lead planning, preparation, and submission of CTAs, MAAs, Orphan Drug Designations, and other filings outside the U.S.
• Serve as primary liaison with EMA, MHRA, PMDA, Health Canada, and other agencies; participate in scientific advice meetings.
• Mentor and manage international regulatory team members and drive cross-functional alignment.
• Ensure compliance and maintain internal processes for global regulatory activities.

Kenntnisse

Leadership

Regulatory strategy

Global submissions

Cross-functional collaboration

Stakeholder management

Ausbildung

Bachelor's degree

Advanced degree in life sciences

Jobbeschreibung

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.

Key Accountabilities/Core Job Responsibilities

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.

Qualifications/Skills

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, Swissmedic) 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 regulatory environments with a forward-thinking, solution-oriented approach High level of professionalism, accountability, and commitment to ethical conduct.

Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a pension, medical stipend, equity and a broad range of other benefits. Denali is committed to its core company value of unity by creating a diverse and inclusive environment.

We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

“Life at Denali” is a living reflection of our values: trust, unity, grit and growth. These are not just words we share—they shape how we show up, collaborate and push boundaries together. From the lab to the community, across functions and milestones, our culture thrives on shared purpose and relentless pursuit.