Senior Director, Regulatory Affairs

BeOne Medicines Ltd.; San Mateo (CA); On-site; USD 260,000 - 380,000; Full time

Job summary

BeOne Medicines Ltd. in California seeks a Senior Director, Regulatory Affairs to lead US regulatory strategy, FDA engagement, and lifecycle management across development programs and marketed products.

You will guide cross-functional teams, anticipate regulatory changes, and shape strategic options for senior leadership. The role requires 15+ years in pharma/biotech, a scientific or health-related degree, and proven experience leading complex US regulatory strategies with direct FDA

Qualifications

• 15+ years of experience in pharma/biotech with US regulatory leadership.
• Bachelor’s degree in a scientific or health-related discipline; advanced degree preferred.
• Direct FDA interaction experience and a track record of regulatory accomplishments.
• Experience leading US regulatory strategies across development, registration, and lifecycle management.
• Oncology experience preferred.

Responsibilities

• Lead development of integrated US regulatory strategies across clinical development and lifecycle management.
• Plan and negotiate FDA engagements and interactions.
• Oversee submissions (INDs, NDAs/BLAs) and complex regulatory filings.
• Provide regulatory risk assessment and cross-functional alignment.
• Build and mentor regulatory talent and ensure inspection readiness.
• Represent Regulatory Affairs in senior governance forums.

Skills

Regulatory leadership

Strategic planning

Stakeholder management

Cross-functional leadership

Regulatory strategy

Education

Bachelor's degree in science/health

Advanced degree preferred

Tools

MS Office

Veeva regulatory publishing

PowerPoint

Job description

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

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.