Senior Director, Global Regulatory Project Management

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 most importantly, share our passionate interest in fighting cancer.

General Description:
The Senior Director of Global Regulatory Project Management is a pivotal leadership role responsible for overseeing and driving the successful execution of regulatory strategies and projects in a dynamic and highly regulated industry and will interact at all levels, including BeOne’s Senior Management. 

This role blends deep expertise in regulatory affairs with best-in-class project management skills to ensure timely, compliant, and strategic submission and approval of products across the globe.

The ideal candidate will have extensive experience leading a diverse team of regulatory project managers and cross-functional project teams, fostering collaboration, innovation, and operational excellence. The ideal candidate is a leader, a strategic thinker, and a hands-on problem solver, committed to advancing organizational objectives.

Essential Functions of the job:
Regulatory Project Leadership, Strategic Planning and Execution, Team Leadership and Development, Stakeholder Engagement and Communication, Risk Management and Problem-Solving.

• Plan, execute, and oversee global regulatory projects, including preparation and submission of INDs, NDAs, BLAs, MAAs, CTAs, and other regulatory filings.

• Develop and implement project management frameworks to ensure regulatory milestones are achieved within scope, timeline, and budget.

• Serve as the primary point of contact for regulatory project status, risks, and mitigation plans, both internally and with external partners.

• Collaborate with Regulatory Affairs, Clinical, CMC, Quality, Safety, and Commercial functions to shape and execute regulatory strategies.

• Anticipate regulatory trends, changes, and challenges, and proactively adapt project plans to align with evolving global requirements.

• Contribute to portfolio prioritization, resource allocation, and business planning processes.

• Lead, mentor, and develop a team of regulatory project managers, fostering a culture of excellence, accountability, and continuous improvement.

• Recruit, onboard, and retain top talent; set clear performance objectives and support career growth.

• Partner with cross-functional leaders to ensure alignment of project goals, deliverables, and timelines.

• Facilitate regular project meetings, steering committees, and executive presentations, providing clear updates and recommendations.

• Identify, assess, and mitigate project risks, including regulatory, operational, and resource-related challenges.

• Resolve project issues with agility and sound judgment; escalate critical matters promptly and constructively.

Supervisory Responsibilities:  

• Yes
   

Computer Skills:   

High Level of Competency Required: 

• Veeva Vault Experience Preferred – including Global & Submission Content Plans

• Microsoft Office and Adobe systems 

• Project Management Tools: Microsoft Project or Smartsheet

• Regulatory Information Management (RIM) Systems (Veeva Vault, Liquent InSight, etc.) 

• Collaboration Tools (SharePoint, etc.)

• Data Visualization Tools (PowerBI, etc.)
   

Travel: <15%

Education/Experience Required:

Bachelor’s degree required. 12+ years’ experience in regulatory affairs and/or regulatory project management within the life sciences industry. Demonstrated track record of successful global regulatory submissions and approvals.

Other Qualifications: 

• Excellent written and visual communication skills

• Excellent presentation and facilitation skills

• Working knowledge of regulations, processes and industry standards that govern regulated systems, records retention, and computer validation quality assurance for the management of regulatory-focused content, throughout the product lifecycle stages, SDLC methodologies and CFR Part 11 and Annex 11 compliance. 

• Knowledge of drug development and submission requirements 

• Demonstrated ability to facilitate, lead, and manage the establishment of procedures. 

• Able to work in a fast-paced environment and effectively manage workload and deliverables under pressure. 

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• 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

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. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process.  Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an 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 accommodationsus@beonemed.com.