Global Regulatory Strategy Director, Oncology Submissions

BeOne Medicines Ltd.; United States; Remote; USD 176.000 - 236.000; Vollzeit

Benefits dieser Stelle

Medical, Dental, Vision

401(k)

FSA/HSA

Paid Time Off

Wellness

Zusammenfassung

BeOne Medicines Ltd. seeks a seasoned Director, Global Regulatory Project Management to shape regulatory strategy across the global oncology portfolio. You will lead cross‑functional teams, influence senior stakeholders, and drive on‑time submissions from US to EU and Asia.

The role blends regulatory expertise with strategic project leadership. The position offers senior leadership responsibility, opportunities for process improvements, and a focus on ensuring global market access for innovative

Qualifikationen

• Bachelor’s degree in Science or related discipline; advanced degree preferred.
• 10+ years of regulatory PM experience with global submissions for small molecules and biologics.
• Experience leading cross‑regional teams and influencing senior stakeholders.

Aufgaben

• Strategic Global Leadership: translate and implement global regulatory strategies across regions.
• Provide regulatory oversight and recommendations for development, submissions, and lifecycle management.
• Lead complex regulatory submissions (IND/CTA, NDA/BLA/MAA) across regions and ensure ICH compliance.
• Organize cross‑functional meetings and drive on‑time, quality submissions.
• Mentor and develop junior staff in regulatory processes and project planning.

Kenntnisse

Strategic leadership

Global regulatory strategy

Regulatory submissions

Cross‑functional leadership

Stakeholder management

Regulatory PM

Ausbildung

Bachelor’s degree in Science or related discipline

Advanced degree preferred

Tools

Smartsheets

MS Project

Power BI

Jobbeschreibung

BeOne Medicines Ltd. seeks a seasoned Director, Global Regulatory Project Management to shape regulatory strategy across the global oncology portfolio. You will lead cross‑functional teams, influence senior stakeholders, and drive on‑time submissions from US to EU and Asia.

The role blends regulatory expertise with strategic project leadership. The position offers senior leadership responsibility, opportunities for process improvements, and a focus on ensuring global market access for innovative