General Description:

The Senior Director, Regulatory Affairs is accountable for developing, implementing, shaping US regulatory direction and U.S. Food and Drug Administration engagement across a development portfolio and marketed products to achieve timely approvals and sustain product value in alignment with business objectives and the global regulatory strategy. This individual provides strategic leadership across all phases of development, registration, post-approval commitments, and lifecycle management, with primary responsibility for U.S. FDA interactions. The incumbent anticipates changes in the U.S. regulatory and healthcare environment, assesses their impact on portfolio and program strategy, and translates complex requirements into clear recommendations for senior management and cross-functional governance decisions, and provides direction on significant regulatory risks. The Senior Director serves as a senior regulatory advisor, leads resolution of critical regulatory issues, and influences program and portfolio decisions through sound judgment, scientific rigor, and business acumen. The role may provide line management, organizational leadership, talent development, and oversight of departmental policies, standards, and continuous-improvement initiatives.

Essential Functions of the job:

·       Leads the development and execution of integrated U.S. regulatory strategies for assigned products and programs across clinical development, registration, post-approval commitments, and lifecycle management.

• Provides authoritative U.S. regulatory advice to global regulatory leaders, development teams, governance committees, and senior management, including assessment of strategic options, risks, trade-offs, and mitigation plans. Integrating US regulatory considerations and advice in collaboration with the global regulatory team to contribute to create an integrated global strategy.
• Serves as the primary regulatory leader for FDA engagement; plans, leads, and negotiates formal and informal interactions to resolve critical issues and advance development and approval objectives.
• Oversees the strategy, preparation, quality, and timely submission of INDs, NDAs, BLAs, supplements, amendments, meeting packages, briefing documents, responses to information requests, and other U.S. regulatory filings.

·       Ensures U.S. regulatory requirements and FDA expectations are incorporated into clinical development plans, evidence-generation strategies, labeling plans, and commercialization and lifecycle decisions.

·       Leads regulatory risk assessment and critical issue management, escalating significant risks with clear options and recommendations and driving cross-functional alignment on mitigation and execution.

·       Maintains expert knowledge of FDA regulations, guidance, policy developments, and precedents; evaluates implications for the portfolio and helps shape consistent organizational positions and standards.

·       Builds effective partnerships with Clinical Development, Medical, Safety, Biostatistics, Clinical Operations, CMC, Quality, Legal, Commercial, and other functions to deliver integrated program and business objectives.

·       Represents Regulatory Affairs on senior cross-functional teams and governance forums and communicates complex regulatory matters clearly and persuasively to internal and external stakeholders.

·       Anticipate high-impact portfolio or program regulatory risks and direct mitigation, escalation, and risk-acceptance decisions. Translate complex regulatory issues into concise, business-relevant recommendations.

·       Shape regulatory practices, operating approaches, innovation, and future-state organizational capability. Leads or contributes to departmental initiatives, operating models, procedures, and process improvements that strengthen quality, compliance, efficiency, and inspection readiness.

·       Recruits, develops, coaches, and retains regulatory talent; establishes clear priorities and performance expectations and fosters accountability, collaboration, inclusion, and continuous learning.

·       May represent the company in external industry forums and regulatory policy discussions relevant to the U.S. business and development portfolio.

Supervisory Responsibilities:

• Extensive supervisory responsibility, both direct and matrixed, for regulatory professionals and potentially multi-level team structures; accountable for capability building, succession planning, performance management, and development of a high-performing U.S. regulatory organization.

Computer Skills:   

• Experience with Microsoft Office suite
• Veeva regulatory publishing
• PowerPoint presentation authoring and presentation

Other Qualifications:   

• 15+ years of experience in the pharmaceutical or biotechnology industry, including significant progressive experience in U.S. Regulatory Affairs and leadership of complex development programs.
• Bachelor’s degree in a scientific or health-related discipline required; advanced scientific, medical, pharmacy, or regulatory degree preferred.
• Demonstrated leadership of complex US regulatory strategies across multiple programs.
• Experience in both early and late-stage oncology preferred
• Demonstrated success as a U.S. regulatory lead with direct FDA interaction experience and a record of significant regulatory accomplishments across development, registration, and lifecycle management.
• Expert knowledge of U.S. drug development regulations, guidance, policy trends, and submission requirements, including INDs and NDAs and/or BLAs; experience with expedited development programs is preferred.
• Experience developing and executing integrated regulatory strategies for complex programs; oncology and both small-molecule and biologic experience are preferred where relevant to the portfolio.
• Proven ability to lead high-stakes FDA interactions, negotiate effectively, resolve ambiguous or precedent-setting issues, and communicate clear recommendations to senior leaders.
• Strong strategic and business acumen, with the ability to balance patient, scientific, regulatory, operational, and commercial considerations and make sound decisions under uncertainty.
• Documented success leading cross-functional teams, influencing without authority, and building alignment across global and U.S. stakeholders.
• Demonstrated people leadership, including recruitment, coaching, performance management, organizational development, and cultivation of future regulatory leaders.
• Excellent written and verbal communication skills, including the ability to synthesize complex information and present persuasive, decision-ready recommendations to executive and external audiences.
• Strong judgment, integrity, collaboration, negotiation, conflict-resolution, and prioritization skills, with the ability to lead multiple complex priorities in a fast-paced environment.

Travel: 

Business travel to be 10-20% as required

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.