BeOne Medicines

BeOne Medicines

Senior Director, Regulatory Affairs

Remote (US) · Director

Sponsorship not specified$211k-$281kDetected 8 days ago
Data AnalysisNegotiationPerformance ManagementFDA RegulatoryLeadershipCommunicationCollaborationProblem SolvingMentoringMicrosoft OfficeBiostatisticsRegulatory Affairs

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odds of building a lasting career here

61Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.

Lottery odds assume a STEM candidate.

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About the role

  • 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.
  • 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.

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.
  • 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.

Requirements

  • 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.
  • Strong strategic and business acumen, with the ability to balance patient, scientific, regulatory, operational, and commercial considerations and make sound decisions under uncertainty.
  • Excellent written and verbal communication skills, including the ability to synthesize complex information and present persuasive, decision-ready recommendations to executive and external audiences.
  • Business travel to be 10-20% as required
  • 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.
  • 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.
  • 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.
  • Strong judgment, integrity, collaboration, negotiation, conflict-resolution, and prioritization skills, with the ability to lead multiple complex priorities in a fast-paced environment.
  • Fosters Teamwork

Nice to have

  • Experience in both early and late-stage oncology preferred
  • 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.
  • oncology and both small-molecule and biologic experience are preferred where relevant to the portfolio.

Skills

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

Compensation

  • $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.
  • 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.

Benefits

  • The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
  • 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.

Company info

  • We are proud to be an equal opportunity employer.
  • 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.
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This listing is sourced directly from BeOne Medicines's careers page and normalized into a canonical job model.