Director, Global Regulatory Lead

Role Summary

The Director, Global Regulatory Lead is responsible for developing, implementing, and advising on global regulatory strategies to secure and maintain market access for product development programs, coordinating with internal stakeholders, and providing leadership across all phases of development, post-approval, and lifecycle management. The role interfaces with business partners externally and leads regulatory strategy for designated projects, with a focus on BeOne’s Hematology Franchise (BTK CDAC and BCL2 assets) on a global regulatory remit.

Responsibilities

• Provides high level global strategic and operational regulatory direction and leadership on projects, including regulatory strategies, requirements for clinical studies and marketing approval in global markets, regulatory strategic development plans and risk assessments, issue management, and health authority interactions.
• Uses extensive knowledge of global regulatory requirements to support development projects and marketed product regulatory issues in alignment with corporate goals.
• Supports preparation and submission of global regulatory documentation to support investigational and marketing registration packages worldwide, ensuring timelines are met; reviews global submission documents for clinical trials and marketing applications and amendments.
• Supports regional teams in negotiating with global regulatory authorities to resolve key issues and expedite approvals of products and labeling changes.
• Maintains awareness of the global regulatory environment and assesses impact on business and product development; facilitates policy and standard interpretation of global regulation.
• Integrates functional expertise with business knowledge to solve problems and make decisions for the overall business.
• Manages and leads an effective global regulatory project team via indirect reporting; builds partnerships with stakeholders from other functions to meet strategic goals.
• Manages critical issues and leads the regulatory contribution; assists with development and implementation of regulatory processes.
• Mentors regulatory professionals and fosters a goal-oriented culture.

Qualifications

• BS with 10+ years, MS with 7+ years, or PhD/MD/PharmD with 5+ years in biotechnical or pharmaceutical industry, plus 5+ years of regulatory experience with deep regulatory knowledge.
• Preferred: experience leading Regulatory Affairs across two or more major geographic areas; prior experience with small molecules and biologics; ability to integrate inputs from multiple regions to develop a global strategy and lead its execution considering risk, timeline, and resources.
• Thorough understanding of drug development and regulatory requirements; ability to assess regulatory implications and influence development strategy.
• Experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, Health Authority interactions, cross-functional leadership, and successful regulatory accomplishments.
• Strong business acumen and strategic thinking; ability to balance short-term needs with long-term vision; proven cross-functional collaboration and professionalism.

Skills

• Excellent interpersonal, oral, and written communication; ability to convey complex issues clearly to internal and external stakeholders.
• Conflict resolution, negotiation, and relationship-building skills; ability to manage multiple projects and priorities.
• Creative problem-solving and ability to develop innovative regulatory solutions.
• Ability to interact with employees, senior management, external partners, and regulatory agencies.

Education

• Not specified beyond degree requirements in Qualifications.

Additional Requirements

• Travel: Must be willing to travel approximately 10-20%.