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

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