[Hiring] Senior Director, Regulatory Affairs @BeiGene

Role Description

The Senior Director, Regulatory Affairs is accountable for developing, implementing, and 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.

• 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.
• 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.
• Anticipates high-impact portfolio or program regulatory risks and directs mitigation, escalation, and risk-acceptance decisions.
• Shapes regulatory practices, operating approaches, innovation, and future-state organizational capability.
• 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.

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.

Requirements

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

Benefits

• Comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
• Eligible for discretionary equity awards and to voluntarily participate 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.

Salary Range

$211,200.00 - $281,200.00 annually. Actual compensation packages are determined by several factors unique to each candidate, including job-related skills, depth of experience, certifications, relevant education or training, and specific work location.