Global Regulatory Lead - Neuroscience Submissions

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

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.