US Regulatory Affairs Director — FDA Strategy & Leadership

BeOne Medicines Ltd.; United States; Vor Ort; USD 211.000 - 281.000; Vollzeit

Zusammenfassung

BeOne Medicines Ltd. is seeking a Senior Director of Regulatory Affairs to lead U.S. regulatory strategy and FDA interactions across a diverse development portfolio. You will shape regulatory direction, advise senior management, and oversee lifecycle management to sustain product value.

The role requires extensive US regulatory leadership experience, strong cross-functional collaboration, and a track record of navigating FDA processes for oncology programs.

Qualifikationen

• Bachelor’s degree in a scientific or health-related discipline.
• Advanced scientific, medical, or regulatory degree preferred.
• Demonstrated leadership of US regulatory strategies across multiple programs.

Aufgaben

• Lead development and execution of integrated US regulatory strategies across clinical development, registration, and lifecycle management.
• Provide authoritative US regulatory advice to global leaders and senior management, assessing options and risks.
• Represent Regulatory Affairs on senior cross-functional teams and manage FDA engagements.

Kenntnisse

Regulatory strategy

FDA engagement

Leadership

Cross-functional collaboration

Regulatory risk assessment

Ausbildung

Bachelor’s degree in science or health-related field

Advanced regulatory degree preferred

Tools

Microsoft Office

Veeva regulatory publishing

PowerPoint

Jobbeschreibung

BeOne Medicines Ltd. is seeking a Senior Director of Regulatory Affairs to lead U.S. regulatory strategy and FDA interactions across a diverse development portfolio. You will shape regulatory direction, advise senior management, and oversee lifecycle management to sustain product value.

The role requires extensive US regulatory leadership experience, strong cross-functional collaboration, and a track record of navigating FDA processes for oncology programs.