[Hiring] Director, Global Regulatory Project and Submission Management @BeiGene

Role Description

The Director, Global Regulatory Project Management (Director, Global RPM) is a senior strategic leader responsible for supporting, influencing, translating, and executing oncology regulatory strategies across the global drug development lifecycle. This role combines deep regulatory expertise with advanced project management and organizational leadership, driving successful NDA/BLA/MAA submissions and ensuring seamless cross-functional integration across regions. The Director, Global RPM proactively anticipates regulatory challenges, influences decisions, and champions process improvements to secure on-time submissions and maintain market access for products worldwide.

Qualifications

• Bachelor’s degree in Science or related discipline; advanced degree preferred.
• Minimum 10+ years of experience in regulatory project management and regulatory submissions, including both small molecules and biologics, with significant global exposure.
• Demonstrated experience in strategic regulatory leadership, with a proven track record of successful submissions and regulatory PM accomplishments in multiple regions.
• Experience leading cross-functional and cross-regional teams, influencing senior stakeholders globally.
• Strong business acumen, strategic thinking, and ability to integrate multiple sources of data for sound decision-making.
• Excellent verbal and written communication skills; able to understand and translate complex regulatory issues clearly to internal and external stakeholders worldwide.
• Skilled in conflict resolution, negotiation, and fostering open communication across cultures.
• PMP or similar certification preferred.

Requirements

• Proficiency with project management and document management tools, such as Smartsheets, MS Project, and Power BI.
• Advanced skills in the Microsoft Office suite (Word, Excel, PowerPoint, Outlook).
• Ability to quickly learn and adapt to new software platforms and digital collaboration tools.
• Experience with electronic document management systems and regulatory submission platforms is preferred.

Benefits

• Comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
• All employees have the opportunity to own shares of BeOne Medicines Ltd. stock through discretionary equity awards and participation in the Employee Stock Purchase Plan.
• Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan.

Supervisory Responsibilities

• Lead and manage complex regulatory submissions (IND/CTA, NDA/BLA/MAA) across multiple regions, ensuring compliance with ICH, US, EU, China, and other international requirements.
• Act as the “COO” to the Global Regulatory Lead, translating strategic regulatory vision into actionable project plans, driving operational execution, and ensuring all cross-functional activities are coordinated and delivered on time.
• Organize and facilitate cross-functional meetings with global teams to coordinate, plan, and track submission activities, driving accountability and alignment among stakeholders worldwide.
• Proactively identify risks, propose solutions, and manage critical issues related to global regulatory submissions and strategy.
• Oversee preparation and submission of documentation to support investigational and marketing registration packages, ensuring timelines and quality standards are met globally.

Travel

• Occasional international and domestic travel may be required to support global project teams, attend regulatory meetings, or participate in industry conferences.
• Travel requirements will vary based on project needs and organizational priorities.

Global Competencies

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range

$176,000.00 - $236,000.00 annually. BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location.

Equal Opportunity Employer

BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [email protected].