Global Regulatory PM Director - Submissions & Strategy

Regulatory Jobs; United States; A distancia; USD 176.000 - 236.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical benefits

Dental benefits

Vision benefits

401(k) with company match

Equity awards

Paid time off

Descripción de la vacante

BeOne Medicines Ltd. in the United States seeks a Director, Global Regulatory Project Management to lead regulatory strategies across US, EU, China, and beyond, driving NDA/BLA/MAA submissions and cross‑functional alignment.

You will guide senior teams, act as COO to GRL, manage global submissions, mentor staff, and champion process improvements to shorten timelines and strengthen market access.

Formación

• Bachelor’s degree in Science or related discipline; advanced degree preferred.
• 10+ years of experience in regulatory project management and regulatory submissions with global exposure.
• Proven track record of successful submissions and regulatory PM accomplishments across regions.
• PMP or similar certification preferred.

Responsabilidades

• Lead complex regulatory submissions (IND/CTA, NDA/BLA/MAA) across multiple regions.
• Act as the COO to the GRL, translating strategic vision into actionable project plans.
• Organize and facilitate cross‑functional meetings to coordinate submission activities.
• Proactively identify risks and manage critical issues in regulatory submissions and strategy.
• Oversee preparation and submission of documentation to support investigational and marketing packages.

Conocimientos

Regulatory leadership

Project management

Global collaboration

Stakeholder management

Regulatory strategy

Educación

Bachelor’s degree in Science

Advanced degree preferred

Herramientas

Smartsheets

MS Project

Power BI

Microsoft Office

Descripción del empleo

BeOne Medicines Ltd. in the United States seeks a Director, Global Regulatory Project Management to lead regulatory strategies across US, EU, China, and beyond, driving NDA/BLA/MAA submissions and cross‑functional alignment.

You will guide senior teams, act as COO to GRL, manage global submissions, mentor staff, and champion process improvements to shorten timelines and strengthen market access.