Beigene

Beigene

Executive Director, Global Regulatory Portfolio Lead

Remote (US) · Director

Sponsorship not specified$285k-$365kDetected 5 days ago
Data AnalysisExcelPerformance ManagementClinical TrialsFDA RegulatoryLeadershipCommunicationCollaborationProblem SolvingMicrosoft OfficeRegulatory Affairs

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.
  • The individual has regulatory affairs departmental and cross-functional influence and acts as an advisor/liaison to senior management and project teams to plan, evaluate and recommend regulatory strategy.

Responsibilities

  • This individual will manage regulatory aspects of compounds through all phases of development, post-approval, and life-cycle of the product.
  • He/she will also provide line management, people development, and performance management as well as support/lead development and implementation of department policies.

Requirements

  • Business acumen and ability to make sound decisions that contribute positively to the business.
  • Required Communication & Interpersonal
  • Required Communication & Interpersonal Skills:
  • BA/BS Degree with 14 plus years of experience in the biotechnical or pharmaceutical industry, and a minimum of 10 years' experience in a Regulatory capacity with a broad background or an MA/MS/MBA with 10 plus years of overall and Regulatory experience.
  • Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends and able to identify and proactively respond to emerging regulatory trends anticipating future challenges and opportunities in strategy, able to identify scientific and/or clinical advances that impact drug development and regulations.
  • Integrates market needs and prioritization into strategy development. Is considered expert in global strategy development and execution with successful track record including extensive regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, interactions with Health Authorities, leading and managing regulatory teams, developing and implementing regulatory strategies with a proven track record.
  • Strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges (e.g., new competition, shifting market environment) and opportunities to expedite development and regulatory processes, and the ability to balance short-term needs with long-term vision.
  • Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism.
  • Excellent interpersonal, oral and written communication skills. Able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to internal and external stakeholders.
  • Negotiating skills and ability to think creatively and develop innovative solutions.
  • Proven ability to build trust and respect within the organization.

Nice to have

  • Preferred candidates will have experience working as a lead in Regulatory Affairs across two or more major geographic areas, and prior experience with both small molecules and biologics.

Skills

  • Skilled in conflict resolution/negotiation. Fosters open communication. Listens and facilitates discussion.
  • Ability to prioritize and handle multiple projects simultaneously.
  • Interacts with BeOne employees and senior management.
  • Interacts with external business partners and Regulatory Agencies.
  • PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
  • Must be willing to travel approximately 10-20%.
  • Global Competencies
  • Fosters Teamwork
  • Provides and Solicits Honest and Actionable Feedback
  • Self-Awareness
  • Acts Inclusively
  • Demonstrates Initiative

Compensation

  • $284,700.00 - $364,700.00 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

  • Externally, the individual will develop the global strategy for interaction with Health Authorities and will interface with business partners regarding development, regulatory, and registration strategies.

Company info

  • 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.

Equal opportunity

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