Manager – Regulatory Program Management & Submission Strategy (Oncology)
Locations:
United States – Pennsylvania, Collegeville
United States – California, La Jolla
United States – Massachusetts, Cambridge
United States – Washington, Bothell
United States – Connecticut, Groton
Employment Type: Full-Time
Posted: 2 Days Ago
Job Requisition ID: 4951412
Role Summary:
Pfizer is seeking a Manager – Regulatory Program Management & Submission Strategy (RPMSS) to provide strategic oversight and operational management of regulatory submissions within the Oncology portfolio. This role ensures alignment with Pfizer’s global regulatory strategies, manages submission timelines, facilitates decision-making, and drives process improvements to ensure timely and high-quality regulatory deliverables.
Key Responsibilities:
Regulatory Program Management
Develop and manage submission timelines and milestones using appropriate project management tools.
Convert submission timelines into actionable tasks, ensuring proactive follow-up and on-time delivery.
Organize and manage GRST, Submission Team, MCI, and leadership alignment meetings including agenda preparation, material distribution, minute-taking, action tracking, and documentation management.
Lead or co-lead regulatory projects, optimizing resource allocation and managing project timelines.
Track and analyze regulatory metrics to support business insights and inform strategic decisions.
Process Optimization & Documentation
Contribute to the design and implementation of workflows to enhance efficiency and standardize best practices.
Maintain templates, dashboards, team rosters, document reviewer lists, SharePoint/Teams sites, and action trackers.
Independently prepare comprehensive status reports, timelines, tables, graphs, correspondence, and presentations for internal and external stakeholders.
Team Support & Training
Assist with onboarding new team members and provide training on project systems, regulatory processes, and workflow tools.
Act as a resource to ensure effective collaboration across cross-functional teams, promoting regulatory compliance and program alignment.
Required Qualifications
Bachelor’s Degree with 4+ years of regulatory or biopharmaceutical project management experience, or Master’s Degree with 2+ years of experience.
2–4+ years of experience in the biopharmaceutical industry, oncology experience preferred.
Proven ability to manage multiple, competing tasks simultaneously in a fast-paced environment.
Experience interacting with senior executive stakeholders and cross-functional teams.
Strong understanding of systems, structures, and processes for efficient regulatory program management.
Key Attributes
Resourceful, proactive, and solutions-oriented with the ability to prioritize responsibilities effectively.
Strong project management skills, attention to detail, and ability to meet tight deadlines.
High energy, creativity, decisiveness, and ability to work independently or in a team.
Sound judgment and discretion in handling confidential information.
Excellent communication skills, both written and verbal, with professionalism at all levels of the organization.
Proficient in MS Word, Excel, PowerPoint, Outlook; familiarity with MS Project preferred.
Demonstrates Pfizer Values and Core Competencies, effectively navigating a matrixed organization.
Experience Required
2–4+ years of regulatory program management or project management experience in oncology or pharmaceutical development.
Demonstrated ability to manage timelines, cross-functional teams, and regulatory submission processes.
Work Arrangement & Benefits
Hybrid role: on-site an average of 2.5 days per week.
Annual base salary: $99,200 – $160,500, with eligibility for Pfizer’s Global Performance Plan (12.5% bonus target) and long-term incentive programs.
Comprehensive benefits including 401(k) with company contributions, paid vacation, parental leave, and health coverage.
Relocation support may be available based on business needs and eligibility.
Why Pfizer
Pfizer is an equal opportunity employer committed to diversity, equity, and inclusion. Join a collaborative environment where you will lead critical regulatory programs, contribute to oncology innovation, and ensure compliance with global regulatory standards.
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