Senior Manager, Regulatory Program Management & Submission Strategy (Oncology)

Role Summary

The Senior Manager, Regulatory Program Management & Submission Strategy (RPMSS) provides comprehensive program management, ensuring alignment and execution of Pfizer Oncology’s regulatory strategic and operational deliverables. The Senior Manager, RPMSS is responsible for ensuring all cross-functional regulatory deliverables are achieved on or ahead of schedule and with quality that meets or exceeds business needs. The role is a key member of the Global Regulatory Strategy Team (GRST). Responsibilities include regulatory strategic and scenario planning, execution of regulatory and submission deliverables, team effectiveness, resource management, risk management, and information and communication management. The RPMSS must have a comprehensive understanding of strategic and tactical planning and the foundational tools that support planning, communication, and continuous improvements in operational delivery.

Responsibilities

• Strategy and Planning: Develop integrated regulatory plans with the Global Regulatory Lead, ensuring alignment with asset strategy and partner line plans.
• Strategy and Planning: Lead regulatory strategy and planning, including scenario assessment, decision criteria, risk management, and stakeholder communication strategies.
• Strategy and Planning: Design, recommend, and implement new processes, approaches, or tools to manage the program or team.
• Strategy and Planning: Develop the regulatory/submission critical path, decision criteria, and milestones or stage gates; ensure alignment with asset strategy and interdependencies.
• Strategy and Planning: Ensure all lines understand regulatory/submission strategy, milestones, and interdependencies.
• Project Execution and Delivery: Provide cross-functional operational expertise to the Global Regulatory Strategy Team.
• Project Execution and Delivery: Develop regulatory goals with the Global Regulatory Lead and monitor progress to ensure on-time delivery within scope.
• Project Execution and Delivery: Monitor activities across regulatory team members to achieve milestones within time, cost, and quality targets.
• Project Execution and Delivery: Negotiate allocation of Partner Line resources to support the regulatory/submission strategy.
• Risk Analysis and Management: Direct the regulatory team in risk management plans, including risk assessment and mitigation.
• Risk Analysis and Management: Proactively identify operational issues, facilitate development of recommendations and actions, and escalate to senior leadership and Partner Lines.
• Risk Analysis and Management: Partner with leadership to identify options to de-risk project plans and capitalize on opportunities.
• Information and Communication Management: Ensure effective, accurate, and timely communication of regulatory information to meet product team and stakeholder needs.
• Information and Communication Management: Provide complete, accurate timeline and resource information in Pfizer systems to enable portfolio management and decision making.
• Team Effectiveness: Use negotiation, facilitation, and conflict resolution skills to enhance cross-functional team performance; ensure all relevant views are incorporated into decisions.
• Team Effectiveness: Identify team performance issues and collaborate with leadership to develop appropriate actions.
• Team Effectiveness: Lead team chartering; clarify deliverables/workload to help Partner Lines assess resource needs and resolve gaps; influence as a key GRST member.
• Submissions: Provide comprehensive project management for regulatory submissions for initial and supplemental market authorizations.
• Submissions: Drive operational excellence, planning, and execution leading to successful submissions and approvals.
• Submissions: Map submission contents and analyze scenarios of cost, schedule, and resources to optimize plans; contribute to endgame submission strategies.

Qualifications

• Required: Bachelor’s Degree with 6+ years of experience or Master’s Degree with 5+ years of experience.
• Required: Command of program management skills and significant expertise in drug development (Oncology preferred).
• Preferred: 6+ years of relevant experience for senior managers.
• Preferred: Professional PM Certification (PMP or equivalent).
• Preferred: Experience with planning and execution of major regulatory submissions (e.g., NDA/BLA/MAA).
• Preferred: Track record of performance, delivery, and team effectiveness in a complex matrix environment.
• Preferred: Proven ability to drive results; knowledge of drug development, medical, and/or commercial disciplines with strategic and operational thinking.
• Preferred: Ability to translate strategy into operational goals and tactical plans; strong leadership, negotiation, interpersonal, communication, and meeting facilitation skills.
• Preferred: Knowledge of clinical operations/clinical trial execution; knowledge of end-to-end drug development (pre-clinical through LOE); experience with Microsoft Project, Planisware, or OnePager; demonstrated breadth of leadership and ability to influence and coach others.

Additional Requirements

• Work Location: Hybrid - onsite an average of 2.5 days per week.