Senior Director, Regulatory Affairs

BeiGene; United States; Remote; USD 211,000 - 281,000; Full time

Job summary

BeOne Medicines Ltd. in the United States seeks an accomplished Regulatory Affairs leader to drive US regulatory strategies for complex oncology programs, including FDA interactions and lifecycle management.

You will shape strategy, lead cross-functional teams, negotiate with FDA, oversee IND/NDAs/BLAs filings, and mentor a growing regulatory group. The role requires 15+ years in pharma/biotech with deep US experience.

Responsibilities

• Leads US regulatory strategy across clinical development, registration, post-approval commitments, and lifecycle management.
• Provides authoritative US regulatory advice to global leaders and senior management, aligning with global strategy.
• Represents Regulatory Affairs on senior cross-functional teams and communicates regulatory matters clearly.
• Manages preparation and submission of INDs, NDAs, BLAs, supplements, and other US filings.
• Ensures FDA expectations are integrated into development plans and labeling and commercialization strategies.
• Drives risk assessment, mitigation, and cross-functional alignment on regulatory issues.
• Leads talent development, recruitment, coaching, and retention of regulatory staff.

Job description

General Description:

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.

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

Salary Range: $211,200.00 - $281,200.00 annually

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 [e-mail].