Global IVD Regulatory CoE Portfolio Manager
At Pfizer, our mission is to deliver breakthroughs that change patients' lives. As the Global IVD Regulatory CoE Portfolio Manager, you will play a critical role in advancing oncology regulatory strategy programs, supporting the development and delivery of innovative medicines and diagnostics.
What You Will Achieve
You will oversee and manage initiatives within the IVD Regulatory Center of Excellence (COE), supporting oncology regulatory strategy programs across the drug development lifecycle. You'll collaborate with cross-functional teams and external partners to drive high-quality IVD co-development program timelines, dashboards, and tools, enabling accurate reporting and decision-making. Your expertise will help resolve project issues, guide operational teams, and facilitate agreements across the enterprise.
How You Will Contribute
- 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.
Must-Have :
Bachelor's degree required; Master's degree preferred.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 :
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).