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 Senior Manager, RPMSS is viewed as a key member of the GRST (Global Regulatory Strategy Team).

The Senior Manager, RPMSS’ responsibilities encompass regulatory strategic and scenario planning, execution of regulatory and submission deliverables, team effectiveness, resource management, risk management, and information and communication management. The Senior Manager, RPMSS needs to have a comprehensive understanding of strategic and tactical planning and the foundational tools that support planning, communication, and continuous improvements in operational delivery.

• Strategy and Planning — Develop integrated regulatory plan in collaboration with the Global Regulatory Lead, ensuring alignment with the asset’s strategic and operational plan and Partner Line plans for the program.
• Strategy and Planning — Provide leadership in regulatory strategy and planning, including development and assessment of scenarios and options, robust decision criteria, risk management, and internal/external communication and stakeholder management strategies.
• Strategy and Planning — Design, recommend, and implement new processes, approaches, or tools to manage the program/team.
• Strategy and Planning — Develop the regulatory/submission critical path, decision criteria, and milestones/stage gates; ensure alignment of regulatory/submission strategy with overarching asset strategy; ensure all lines understand regulatory/submission strategy, key 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 in partnership with the Global Regulatory Lead and closely monitor progress against these goals for operational efficiency, ensuring the program delivers on time and within scope.
• Project Execution and Delivery — Monitor activities across all regulatory team members and associated lines to ensure achievement of key decision points and milestones according to time, cost, and quality parameters of the endorsed plan.
• Project Execution and Delivery — Negotiate the allocation of Partner Line resources to support the endorsed regulatory/submission strategy.
• Risk Analysis and Management — Direct the regulatory team in the preparation, implementation, maintenance, communication, and management of integrated risk management plans, including risk assessment and risk mitigation strategies.
• Risk Analysis and Management — Proactively identify operational issues, facilitate development of team recommendations and action options, and ensure appropriate escalation to senior leadership and Partner Lines.
• Risk Analysis and Management — Partner with team and department 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 the needs of the product team and stakeholders.
• Information and Communication Management — Provide complete, accurate, and timely timeline and resource information in appropriate Pfizer systems to enable effective portfolio management and decision making.
• Team Effectiveness — Utilize negotiation, facilitation, meeting management, and conflict resolution skills to enhance cross-functional team performance.
• Team Effectiveness — Ensure all appropriate team member views have been raised and incorporated into team decisions as appropriate.
• Team Effectiveness — Identify team performance issues and partner with team leadership to recommend and develop appropriate actions.
• Team Effectiveness — Lead team chartering process.
• Team Effectiveness — Clarify project deliverables/workload to enable…