Global IVD Regulatory Center of Excellence Portfolio Manager

Pfizer • La Jolla, CA

19d • Hybrid

About The Position

Why Patients Need You 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.

Requirements

• 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 Haves

• 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).
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

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.

Benefits

• participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% of the base salary and eligibility to participate in our share based long term incentive program
• comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments
• Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees