Director, Regulatory Affairs – NA Strategy Lead

BeOne Medicines Ltd.; San Mateo (CA); On-site; USD 180,000 - 250,000; Full time

Job summary

BeOne Medicines Ltd. seeks a Director, Regulatory Affairs to lead North America regulatory strategies for development programs, ensuring market access in the NA region.

You will guide regulatory activities from development through life cycle, interface with FDA and Health Canada, and collaborate with the global regulatory leader to align with business objectives. You will mentor a regional regulatory team, shape regulatory processes, and provide strategic oversight across projects while

Qualifications

• 10+ years of experience in the biotechnical or pharmaceutical industry, with a minimum of 5 years in a regulatory capacity
• Bachelor’s degree required; advanced degree preferred
• Experience leading regulatory strategies for FDA and Health Authority interactions
• Strong understanding of US and Canada regulatory requirements for drug development
• Proven track record of managing regulatory teams and delivering regulatory milestones

Responsibilities

• Provide high level regulatory strategic and operational direction for NA and mentorship on projects
• Oversee preparation and submission of regulatory documentation for US and Canada
• Liaise with FDA and Health Canada to expedite approvals and manage issues
• Ensure compliance with global regulatory requirements and adapt to policy changes
• Build and coach a regional regulatory team and collaborate with cross-functional partners
• Develop and implement regulatory processes and governance

Skills

Regulatory strategy

Regulatory leadership

FDA interactions

Cross-functional leadership

Mentoring

Education

Bachelor's degree

Advanced degree

Tools

Veeva regulatory publishing

Microsoft Office

PowerPoint

Job description

BeOne Medicines Ltd. seeks a Director, Regulatory Affairs to lead North America regulatory strategies for development programs, ensuring market access in the NA region.

You will guide regulatory activities from development through life cycle, interface with FDA and Health Canada, and collaborate with the global regulatory leader to align with business objectives. You will mentor a regional regulatory team, shape regulatory processes, and provide strategic oversight across projects while