Global Regulatory Strategy Director, Neuroscience

Denali Therapeutics Inc.; Zürich; Vor Ort; CHF 260.000 - 340.000; Vollzeit

Benefits dieser Stelle

Pension

Medical stipend

Equity

Zusammenfassung

Denali Therapeutics Inc. is seeking a high-caliber Function Lead, International Regulatory to drive global regulatory strategy across clinical and commercial neuroscience programs.

You will lead interactions with external authorities and oversee a team of regulatory professionals, ensuring compliant, timely submissions and strategic planning. The role emphasizes global leadership, cross-functional collaboration, and mentorship, with a focus on CTAs, MAAs, and regional regulatory requirements.

Qualifikationen

• Bachelor’s degree required; advanced degree in life sciences or related discipline strongly preferred.
• 12+ years of regulatory affairs experience in pharmaceutical/biotech, with at least 8+ years international regulatory affairs.
• Direct experience with major international regulatory agencies including EMA, PMDA, Health Canada, TGA and Swissmedic.
• Proven success leading global submissions (CTAs, MAAs) and developing international regulatory strategies.
• Strong leadership, decision-making and project management with cross-functional impact.
• Excellent communication and ability to interact with senior leadership and regulators.

Aufgaben

• Develop and implement international regulatory strategies across the global portfolio.
• Lead planning and submission of CTAs, MAAs, Orphan Drug Designations and other filings.
• Serve as primary liaison with EMA, MHRA, PMDA, Health Canada and other authorities.
• Collaborate with cross-functional teams to support global trials and product registrations.
• Monitor global regulatory developments and translate into actionable strategies.
• Maintain quality and consistency of international regulatory submissions and communications.
• Develop and maintain internal processes, templates and training for global activities.
• Partner with affiliates, CROs and local consultants to ensure compliance and timely submissions.
• Support global labeling strategies aligned with U.S. labeling where applicable.
• Mentor and develop international regulatory team members; lead through annual goal setting.

Kenntnisse

Leadership

Regulatory strategy

Global submissions

Project management

Stakeholder communication

Ausbildung

Bachelor’s degree

Advanced life sciences degree

Jobbeschreibung

Denali Therapeutics Inc. is seeking a high-caliber Function Lead, International Regulatory to drive global regulatory strategy across clinical and commercial neuroscience programs.

You will lead interactions with external authorities and oversee a team of regulatory professionals, ensuring compliant, timely submissions and strategic planning. The role emphasizes global leadership, cross-functional collaboration, and mentorship, with a focus on CTAs, MAAs, and regional regulatory requirements.