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

Role Summary

The Senior Manager, Regulatory Program Management & Submission Strategy (Oncology) provides comprehensive program management to align and execute Pfizer Oncology’s regulatory strategic and operational deliverables. The role ensures cross-functional regulatory deliverables are met on time and with quality, and serves as a key member of the Global Regulatory Strategy Team (GRST). Responsibilities include regulatory strategy and scenario planning, submission delivery, risk and information management, and team effectiveness, leveraging strategic and tactical planning tools to improve operational delivery.

Responsibilities

• Strategy and Planning: Develop an integrated regulatory plan with the Global Regulatory Lead and ensure alignment with the asset strategy and Partner Line plans for the program; provide leadership in regulatory strategy and planning, including scenario development, decision criteria, risk management, and stakeholder management strategies; design, recommend, and implement new processes, approaches, or tools to manage the program/team; develop the regulatory/submission critical path, decision criteria, and milestones; ensure regulatory/submission strategy alignment with the asset strategy; ensure all lines understand the strategy, milestones, and interdependencies.
• Project Execution and Delivery: Provide cross-functional operational expertise to the Global Regulatory Strategy Team; develop regulatory goals with the Global Regulatory Lead and monitor progress for operational efficiency to deliver on time and within scope; monitor activities across regulatory team members to achieve milestones per the endorsed plan; negotiate the allocation of Partner Line resources to support the regulatory/submission strategy.
• Risk Analysis and Management: Direct the regulatory team in risk management planning, assessment, and mitigation; proactively identify operational issues and develop recommendations and action options with appropriate escalation to senior leadership and Partner Lines; partner with leadership to identify de-risking options 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; provide complete, accurate timeline and resource information in Pfizer systems to enable portfolio management and decision making.
• Team Effectiveness: Utilize negotiation, facilitation, meeting management, and conflict resolution skills to enhance cross-functional team performance; ensure all appropriate views are raised and considered; identify performance issues and develop actions; lead team chartering and clarify deliverables/workloads to enable resource planning; influence as a key member of the GRST.
• Submissions: Manage regulatory submission activities for initial and supplemental market authorizations; drive operational excellence, planning, and execution to achieve successful submissions and approvals; map submission contents and conduct scenario analyses of cost, schedule, and resource demands; contribute to endgame submission planning and resourcing (in partnership with the Project Planner).

Qualifications

• Required: Bachelor’s Degree with 6+ years of experience or Master’s Degree with 5+ years of experience; strong program management skills with substantial expertise in drug development (Oncology preferred).
• Required: Experience with planning and execution of major regulatory submissions (e.g., NDA/BLA/MAA) is preferred; track record of performance, delivery, and team effectiveness in a complex matrix environment; strong ability to think strategically and operationally.
• Preferred: Senior Manager-level experience with 6+ years of relevant experience; Professional PM Certification (PMP or equivalent) desirable.
• Preferred: Knowledge of clinical operations/clinical trial execution and end-to-end drug development (pre-clinical through LOE); experience with Microsoft Project, Planisware, and/or OnePager; demonstrated leadership, negotiation, interpersonal, communication, and facilitation skills.

Education

• Bachelor’s Degree with 6+ years of experience or Master’s Degree with 5+ years of experience
• Professional PM Certification (PMP or equivalent) desirable

Skills

• Program management
• Regulatory strategy and submission planning
• Risk management and mitigation
• Cross-functional leadership and stakeholder management
• Negotiation, facilitation, and conflict resolution
• Strategic and operational thinking
• Communication and information management
• Clinical development knowledge ( Oncology preferred )

Additional Requirements

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