Executive Director, Global Regulatory Portfolio Lead

Overview

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and share our passionate interest in fighting cancer.

The Executive Director, Global Regulatory Portfolio Lead is responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives. This role manages regulatory aspects of compounds through all phases of development, post‑approval, and life‑cycle of the product, provides leadership and strategic regulatory oversight, and acts as an advisor/liaison to senior management and project teams.

• Uses extensive knowledge of the global regulatory environment and applies it both strategically and operationally to development portfolio and projects.
• Provides high‑level strategic and operational regulatory direction and leadership on projects including global regulatory strategies, regulatory requirements for clinical studies and marketing approval, regulatory strategic development plans, risk assessments, critical issue management, and advice on Health Authority interactions.
• Oversees the preparation of global regulatory documentation and ensures timelines are met, including review of global submission documents for clinical trials and marketing applications and their amendments.
• Supports the regional team to negotiate with global regulatory authorities, resolve key regulatory issues, and expedite approvals of product and labeling changes.
• Maintains awareness of the global regulatory environment and assesses the impact of changes on business and product development programs.
• Facilitates policy and development of standard interpretation of global regulation.
• Integrates functional expertise with business knowledge to solve problems and make good decisions for the overall business.
• Trains, develops, and manages an effective regulatory team via direct and indirect reporting structure.
• Builds partnerships with key stakeholders to ensure that strategic business goals are met.
• Manages critical issues in collaboration with the regions, taking leadership when more than one region is impacted.
• Assists with the development and implementation of regulatory processes.
• Recruits, develops, manages, and mentors regulatory professionals and helps create a goal‑oriented culture.

• BA/BS degree with 14+ years of experience in the biotechnical or pharmaceutical industry and a minimum of 10 years in a regulatory capacity; or MA/MS/MBA with 10+ years overall and regulatory experience.
• Preferred candidates have experience leading regulatory affairs across two or more major geographic areas and prior experience with both small molecules and biologics.
• Thorough understanding of drug development process and regulatory requirements, and the ability to proactively respond to emerging regulatory trends and scientific advances.
• Expert in global strategy development and execution, including INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, interactions with Health Authorities, and leading regulatory teams.
• Business acumen and ability to make sound decisions that contribute positively to the business.
• Strategic skills including creativity, effectiveness in identifying and addressing major challenges and opportunities, and balancing short‑term needs with long‑term vision.
• Proven ability to deliver on goals within a cross‑functional team/partnership environment with high professionalism.

• Excellent interpersonal, oral, and written communication skills with the ability to analyze and convey complex issues persuasively.
• Skilled in conflict resolution/negotiation, open communication, listening, and facilitation of discussion.
• Negotiating skills and creative problem‑solving ability.
• Ability to build trust and respect within the organization.
• Ability to prioritize and handle multiple projects simultaneously.
• Interacts with BeOne employees and senior management as…