Hiring: Global IVD Regulatory Center of Excellence (COE) Portfolio Manager
📍 Locations:
United States: California (La Jolla, South San Francisco), Washington (Bothell), Connecticut (Groton), Pennsylvania (Collegeville), New York (New York City)
💼 Job Type: Full-time
🆔 Job ID: 4944626
📅 Posted: 6 Days Ago
🌐 Work Arrangement: Hybrid
About Pfizer
Pfizer is dedicated to delivering breakthroughs that change patients’ lives. The IVD Regulatory Center of Excellence (COE) plays a vital role in advancing oncology regulatory strategies and supporting innovative medicines and diagnostics development.
Role Summary
The Global IVD Regulatory COE Portfolio Manager oversees and manages a portfolio of IVD regulatory projects, ensuring alignment across cross-functional teams and external partners. This role drives timelines, dashboards, and tools to enable accurate reporting and decision-making while resolving project issues and guiding operational teams.
Key Responsibilities
Portfolio & Project Management
Oversee global IVD regulatory projects, ensuring timely initiation and execution of study start-up activities.
Plan and schedule project timelines and milestones prior to study initiation.
Forecast and allocate resources (people, financial, technology) across the IVD COE portfolio.
Facilitate cross-functional issue resolution and mitigation.
Coordinate discussions between Oncology Regulatory Strategy and CTRSE Regulatory PM (GSPM) for alignment.
Operational Excellence & Collaboration
Manage pre-studies, projects, and initiatives to improve operational efficiencies.
Facilitate dissemination of educational and training materials for new methodologies.
Build partnerships with internal and external stakeholders to support project goals.
Qualifications
Must-Have
Bachelor’s degree (Master’s preferred).
Direct experience leading projects in highly regulated environments.
Proven ability to manage multiple projects with competing deadlines.
Knowledge of IVD manufacturing and associated processes.
Strong oral and written communication skills.
Proficiency with Microsoft applications.
Nice-to-Have
Experience managing pharmaceutical, technical, IVD, or medical device projects or clinical programs.
Experience leading regulatory submissions for IVD and/or drug applications.
Familiarity with Microsoft Project or equivalent project management tools.
Certification in operational excellence methodologies (e.g., Six Sigma, Lean).
Competencies
Leadership: Ability to influence, collaborate, coach, and guide colleagues across teams.
Strategic thinking: Aligns regulatory and operational objectives across enterprise programs.
Problem-solving: Resolves project issues and mitigates risks proactively.
Communication: Effectively engages cross-functional and external partners.
Compensation & Benefits
Salary Range: $120,800 – $201,400
Bonus: Pfizer Global Performance Plan (17.5% target)
Benefits: 401(k) with matching contributions, retirement savings, paid vacation/holidays, medical, dental, vision, parental leave, and more.
Relocation: Assistance may be available based on business needs and eligibility.
Equal Opportunity & Eligibility
Pfizer is an equal opportunity employer. Permanent U.S. work authorization is required. Pfizer complies with all applicable nondiscrimination, work authorization, and accessibility laws.
🔗 Apply Now: Pfizer Careers – Global IVD Regulatory COE Portfolio Manager
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