Director, Global Regulatory Lead

Role Summary

Director, Global Regulatory Lead. BeOne seeks experienced professionals to develop and guide global regulatory strategies to secure and maintain market access for products, coordinating with internal stakeholders and interfacing with external partners. Focus is on BeOne’s Hematology Franchise, including BTK CDAC and BCL2 assets, with 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.
• Applies extensive knowledge of global regulatory requirements to support development projects and marketed product regulatory issues to corporate goals.
• Supports preparation and submission of global regulatory documentation to support investigational and marketing registration packages worldwide, ensuring timelines are met.
• Supports regional teams to negotiate with global regulatory authorities and expedite approvals of product and labeling changes.
• Maintains awareness of global regulatory environment and assesses impact on business and development programs; facilitates policy development and standard interpretation of global regulation.
• Integrates functional expertise with business knowledge to solve problems and make sound decisions for the business.
• Manages and leads a global regulatory project team via indirect reporting; builds partnerships with other functions to meet strategic goals.
• Manages critical issues and leads regulatory contributions; assists with developing and implementing 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 in a regulatory role with broad regulatory knowledge.
• 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 global strategy and lead execution with consideration of risk, timeline, and resources.
• Thorough understanding of drug development and regulatory requirements; ability to analyze scientific data to influence development strategy and regulatory strategy.
• Regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, Health Authority interactions, leading cross-functional teams, and delivering significant regulatory accomplishments.
• Strong business acumen, strategic thinking, and ability to deliver goals in a cross-functional environment.

Skills

• Excellent interpersonal, oral and written communication; ability to convey complex issues to internal and external stakeholders.
• Conflict resolution/negotiation, openness to discussion, and ability to build trust within the organization.
• Creative thinking, negotiation skills, and ability to develop innovative solutions.
• Ability to prioritize and manage multiple projects; comfort interacting with senior management and external partners.

Education

• Not specified beyond degree requirements in Qualifications.

Additional Requirements

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