• Job Description

  Req#: R20809

  BeiGene 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 position requires a highly skilled and detail-oriented project manager to drive project management initiatives across the Global Regulatory Operations organization.

  This role will be responsible for managing regulatory operations projects, driving strategies across the Global Regulatory Affairs (GRA) & Global Regulatory Operations (RO) organization, by collaborating with cross functional teams (RA, IT, QA etc.) to implement regulatory systems while supporting process improvement initiatives.

  The ideal candidate has a strong background in regulatory affairs, project management, and process optimization.

  
  The GRO Project Manager will provide global project oversight and support, including budgeting and resource planning, in collaboration with key GRA stakeholders.

  This role will work closely with project teams, IT R&D lead, IT Project Management Office (PMO), and business stakeholders to ensure systems and processes are implemented/upgraded on time, within budget and in compliance with relevant standards and regulatory requirements.

  Essential Functions of the job:

  • Responsible for all aspects of GRO business project management function from project planning phase through to completion, managing all phases of project execution in collaboration with project lead(s).

  • Define, develop, and execute project plans specifying goals, strategy, resources, scheduling, identification of risks, and contingency plans.

  • Support assigned projects and programs (e.g., Veeva Vault Submissions (VVS), RIM), including coordinating project meetings, updating project documentation, and monitoring project status.

  • Serve as the primary contact for business (e.g., GRA) on all assigned projects.

  • Provide routine updates and executive summaries (in collaboration with IT PMO and IT Application support team) on project status to key stakeholders and management. Provide expertise, guidance, and leadership in regulatory system processes related to information management, submission publishing and validation, and regulatory system strategies.

  • Develop and/or maintain up-to-date knowledge of global standards and procedures for regulatory technology and submissions, including eCTD, IDMP, and publishing standards.

  • Be familiar with new and revised regulatory guidance and coordinate impact assessment on systems used within Regulatory.

  • Collaborate in evaluation of new tools and technologies and provide project direction and support to the team on execution of Regulatory systems strategy.

  • In partnership with GTS, ensure that Regulatory technology requirements are incorporated and supported by new systems or system upgrades.

  • Drive process improvements and standardization to project management processes and tools while collaborating with GRA & GRO stakeholders.

  • Work across geographic regions to ensure project support needs are met.

  Supervisory Responsibilities:

  • None currently, may develop in future

  Education Required:

  • 7+ years in the pharmaceutical/bio-pharmaceutical industry with prior Regulatory Operations and Project Management related experience.

  • Bachelor's Degree preferred, but equivalent experience considered.

  BeiGene Global Competencies

  When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, 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: $134,800.00 - $179,800.00 annually

  BeiGene 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 BeiGene 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 and we value diversity. BeiGene 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.

• About the company

  BeiGene is a biotechnology company that specializes in the development of drugs for cancer treatment.

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