Global IVD Regulatory Center of Excellence Portfolio Manager

Role Summary

The Global IVD Regulatory COE Portfolio Manager leads initiatives within the IVD Regulatory Center of Excellence, supporting oncology regulatory strategy programs across the drug development lifecycle. Collaborates with cross-functional teams and external partners to drive high-quality IVD co-development program timelines, dashboards, and tools, enabling accurate reporting and informed decision-making. Guides operational teams and facilitates agreements across the enterprise.

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

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

Education

• Bachelor’s degree required
• Masters Degree preferred

Additional Requirements

• Relocation support available
• Work Location: Hybrid or Remote; if hybrid, live within commuting distance and work on-site an average of 2.5 days per week