Global IVD Regulatory Center of Excellence Portfolio Manager

Role Summary

Global IVD Regulatory Center of Excellence Portfolio Manager. Manage initiatives within the IVD Regulatory COE to support oncology regulatory strategy programs across the drug development lifecycle, collaborating with cross-functional teams and external partners to drive program timelines, dashboards, and tools.

Responsibilities

• Oversee a global portfolio of IVD regulatory projects, ensuring timely initiation and execution of cross-functional study start-up activities.
• Plan and schedule project timelines and milestones using appropriate tools prior to study start-up.
• Forecast and plan resource requirements (people, financial, technology) for projects across the IVD Regulatory COE/Portfolio.
• Lead and support cross-functional issue resolution and mitigation activities, both internally and externally.
• Coordinate and lead discussions between Oncology Regulatory Strategy and CTRSE Regulatory PM (GSPM) to ensure alignment of decisions.
• Manage and participate in pre-studies, projects, and other activities to increase operational efficiencies and support business imperatives.
• Facilitate dissemination of educational and training materials to advance new concepts and methodologies.

Qualifications

• Must-Have:
  • Bachelor’s degree required with 4 years experience
  • Direct experience leading projects in a highly regulated environment
  • Proven ability to manage multiple projects with competing deadlines
  • Knowledge of IVD manufacturing and associated processes
  • Excellent oral and written communication skills
  • Proficiency with Microsoft applications
• Nice-to-Have:
  • Masters Degree preferred
  • Experience managing pharmaceutical, technical, IVD, or medical device projects and/or clinical programs
  • Experience leading regulatory submissions for IVD and/or drug applications
  • Experience with Microsoft Project or equivalent systems
  • Certification in operational excellence methodologies (e.g., Six Sigma, Lean)

Skills

• Regulatory project management
• Cross-functional collaboration
• Strategic planning and scheduling
• Resource forecasting
• Regulatory submissions (IVD/drug)
• Communication (oral and written)
• Microsoft Office competencies

Education

• Bachelor’s degree required (4+ years experience); Masters preferred

Additional Requirements

• Hybrid work arrangement; on-site ~2.5 days per week within commuting distance
• Relocation support available