Senior Director, Regulatory Affairs

BeOne Medicines

. Develop and execute integrated U.S.

Posted 10/2/2026full-timeRemote • United StatesSenior💰 $211,200 - $281,200 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in U.S. Regulatory Affairs with a focus on developing and executing integrated regulatory strategies for complex pharmaceutical and biotechnology programs. Proven leadership in FDA interactions, regulatory submissions, and cross-functional team alignment.

Highest-signal resume keywords

U.S. Regulatory Affairs LeadershipFDA Interaction ExperienceIntegrated Regulatory Strategy DevelopmentOncology Drug Development KnowledgeCross-Functional Team Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

U.S. Drug Development RegulationsIND SubmissionNDA SubmissionBLA SubmissionRegulatory Risk AssessmentRegulatory Strategy ExecutionComplex Program ManagementRegulatory ComplianceSubmission Requirements KnowledgeExpedited Development Programs

Soft Skills

LeadershipNegotiationCollaborationConflict ResolutionStrategic Decision-Making

Tools & Technologies

Microsoft Office SuiteVeeva Regulatory PublishingPowerPoint

Industry Keywords

Pharmaceutical IndustryBiotechnology IndustryOncologyClinical DevelopmentLifecycle Management

About the role

Key responsibilities & impact

Develop and execute integrated U.S. regulatory strategies for assigned products and programs across clinical development, registration, post-approval commitments, and lifecycle management
Provide authoritative U.S. regulatory advice to global regulatory leaders, development teams, governance committees, and senior management
Assess strategic options, risks, trade-offs, and mitigation plans and integrate U.S. regulatory considerations into global strategies
Serve as the primary regulatory leader for FDA engagement, planning, leading, and negotiating formal and informal interactions
Oversee 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
Incorporate U.S. regulatory requirements and FDA expectations into clinical development plans, evidence-generation strategies, labeling plans, and commercialization and lifecycle decisions
Lead regulatory risk assessment and critical issue management, escalating significant risks and driving cross-functional alignment on mitigation and execution
Maintain expert knowledge of FDA regulations, guidance, policy developments, and precedents and evaluate portfolio implications
Build partnerships with Clinical Development, Medical, Safety, Biostatistics, Clinical Operations, CMC, Quality, Legal, Commercial, and other functions
Represent Regulatory Affairs on senior cross-functional teams and governance forums and communicate complex regulatory matters to stakeholders
Anticipate high-impact portfolio or program regulatory risks and direct mitigation, escalation, and risk-acceptance decisions
Shape regulatory practices, operating approaches, innovation, future-state organizational capability, procedures, and process improvements
Recruit, develop, coach, and retain regulatory talent; establish priorities and performance expectations
Provide direct and matrixed supervision, capability building, succession planning, performance management, and development of a high-performing U.S. regulatory organization
Represent the company in external industry forums and regulatory policy discussions as needed

Requirements

What you’ll need

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 U.S. 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 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 preferred
Experience developing and executing integrated regulatory strategies for complex programs
Oncology and both small-molecule and biologic experience 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
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
Strong judgment, integrity, collaboration, negotiation, conflict-resolution, and prioritization skills
Experience with Microsoft Office suite
Veeva regulatory publishing
PowerPoint presentation authoring and presentation
Business travel availability of 10–20% as required

Benefits

Comp & perks

Annual bonus plan eligibility for non-commercial roles
Incentive compensation plan eligibility for commercial roles
Discretionary equity awards
Employee Stock Purchase Plan
Medical insurance
Dental insurance
Vision insurance
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness benefits
Equal opportunity employer and reasonable accommodation support