Senior Regulatory Affairs Director, FDA Strategy

BeOne Medicines Ltd.; California; On-site; USD 180,000 - 280,000; Full time

Job summary

BeOne Medicines Ltd. seeks a seasoned Regulatory Affairs leader to manage, evaluate, and complete regulatory projects aligned with company goals.

The role develops and implements regulatory strategies for development programs to ensure market access and life-cycle management, coordinating with internal teams and external partners. The Associate Director will provide strategic regulatory guidance, interface with Health Authorities, and lead department policy development to meet evolving

Qualifications

• Bachelor's degree with 8+ years of related regulatory experience.
• Experience leading FDA interactions and regulatory teams is preferred.
• Strong understanding of US and international regulatory requirements.
• Ability to develop and implement regulatory strategies and lifecycle plans.

Responsibilities

• Develop and oversee regulatory strategies for development programs to secure market access.
• Lead and coordinate regulatory deliverables across IND/CTA, NDA/MAA submissions and lifecycle activities.
• Interface with Health Authorities and internal/external stakeholders to address regulatory issues.
• Mentor and supervise junior regulatory staff; manage timelines and deliverables.
• Maintain up-to-date knowledge of regulatory requirements and policy trends.

Skills

Regulatory strategy

Leadership

Communication

Negotiation

Project management

Cross-functional collaboration

Regulatory affairs

Education

Bachelor's degree in Life Sciences

Advanced degree preferred

Tools

MS Office

Job description

BeOne Medicines Ltd. seeks a seasoned Regulatory Affairs leader to manage, evaluate, and complete regulatory projects aligned with company goals.

The role develops and implements regulatory strategies for development programs to ensure market access and life-cycle management, coordinating with internal teams and external partners. The Associate Director will provide strategic regulatory guidance, interface with Health Authorities, and lead department policy development to meet evolving