Head of NA Regulatory Affairs & FDA Strategy

BeiGene; United States; Remote; USD 176,000 - 236,000; Full time

Job summary

BeOne Medicines Ltd. is seeking a Director of Regulatory Affairs to lead NA regulatory strategies for development programs in the US and Canada, coordinating with the global regulatory leader.

You will manage regulatory aspects across all development phases, liaising with the FDA and Health Canada, and guiding the NA team to ensure timely, compliant submissions. The role requires 10+ years in biotech/pharma with ≥5 years in regulatory leadership, strong strategic and negotiation skills, and a

Qualifications

• 10+ years in biotechnical/pharmaceutical industry with ≥5 years in Regulatory
• Bachelor’s degree required; advanced degree preferred
• Experience leading regulatory affairs with FDA; exposure to small molecules and biologics
• Deep understanding of drug development and regulatory trends
• Extensive regulatory experience with INDs/CTAs, NDAs/BLAs, lifecycle management
• Strong business acumen and decision-making
• Excellent strategic thinking with ability to navigate competition and market changes
• Proven ability to deliver goals in cross-functional teams
• Excellent verbal and written communication; strong negotiation skills
• Ability to mentor and develop regulatory teams

Responsibilities

• Provide regulatory strategy and operational direction for NA
• Liaise with FDA and Health Canada to resolve regulatory issues
• Oversee preparation and submission of regulatory packages in US/Canada
• Review sections of clinical trial and marketing documents for regulatory compliance
• Develop and implement regulatory strategies aligned with global goals
• Mentor and manage a regional regulatory team
• Collaborate with senior stakeholders to meet business goals
• Lead critical regulatory issues and issue escalation as needed
• Contribute to regulatory process improvements
• Interact with external partners and regulatory agencies

Skills

Regulatory strategy

FDA/Health Canada liaison

People management

Cross-functional collaboration

Regulatory submissions (INDs/CTAs, ND&

Strategic thinking

Negotiation

Education

Bachelor's degree

Advanced degree preferred

Tools

Veeva regulatory publishing

Microsoft Office

PowerPoint

Job description

BeOne Medicines Ltd. is seeking a Director of Regulatory Affairs to lead NA regulatory strategies for development programs in the US and Canada, coordinating with the global regulatory leader.

You will manage regulatory aspects across all development phases, liaising with the FDA and Health Canada, and guiding the NA team to ensure timely, compliant submissions. The role requires 10+ years in biotech/pharma with ≥5 years in regulatory leadership, strong strategic and negotiation skills, and a