Director, Regulatory Program Management & Submission Strategy (Oncology)

Role Summary

Director, Regulatory Program Management & Submission Strategy (Oncology) responsible for comprehensive program management to ensure alignment and execution of regulatory strategic and operational deliverables in Pfizer Oncology. Serves as regulatory program operational leader and key member of the Global Regulatory Strategy Team, overseeing regulatory strategy, submission deliverables, team effectiveness, risk management, and information/communication management.

Responsibilities

• Strategy and Planning: Develop integrated regulatory plans aligned with asset strategy and Partner Line plans; span from Pre-Clinical to Loss of Exclusivity. Provide leadership in regulatory strategy, scenario planning, risk management, and stakeholder communication; design and implement new processes/tools; lead regulatory/submission critical path and milestones; ensure cross-line alignment.
• Project Execution and Delivery: Provide cross-functional operational leadership to the Global Regulatory Strategy Team; coordinate goals with the Global Regulatory Lead; monitor progress for on-time, within-scope delivery; manage timelines and resources across regulatory team members and lines; influence leadership for efficient delivery; negotiate Partner Line resource allocation.
• Risk Analysis and Management: Lead integrated risk management plans, assess risks, implement mitigation strategies, escalate issues to senior leadership and Partner Lines; identify de-risking options and opportunities.
• Information and Communication Management: Ensure timely, accurate regulatory information for product teams and stakeholders; maintain timeline and resource data in Pfizer systems for portfolio management and decision making.
• Team Effectiveness: Enhance cross-functional team performance through negotiation, facilitation, and conflict resolution; incorporate diverse views into decisions; manage team chartering and resource planning; influence as GRST leader.
• Submissions: Manage regulatory submission activities for initial and supplemental market authorizations; drive operational excellence in submissions and approvals; plan up to 18 months in advance of potential submissions; optimize endgame submission plans; develop submission integrated MS project plans with Project Planner support.

Qualifications

• Bachelor's degree in drug development or business required; advanced degree (PhD, PharmD, MBA) desirable.
• Mastery of program management with significant drug development experience (Oncology preferred); 10+ years of relevant experience strongly preferred for Directors.
• Professional PM Certification (PMP or equivalent) desirable.
• Experience leading planning and execution of major regulatory submissions (NDA/BLA/MAA) required.
• Strong track record in delivery and team effectiveness in a complex matrix; proven ability to drive results.
• Extensive knowledge of drug development, medical/commercial disciplines; ability to translate strategy into operational goals and plans.
• Strong leadership, negotiation, interpersonal, communication, and meeting facilitation skills.
• Desirable: knowledge of clinical operations/trial execution and end-to-end drug development; experience with Microsoft Project, Planisware, OnePager.

Skills

• Strategic thinking and operational execution
• Cross-functional leadership
• Risk management and mitigation
• Regulatory strategy and submission planning
• Communication and stakeholder management
• Project planning and resource management
• Negotiation and conflict resolution

Education

• Bachelor's degree in relevant field; advanced degree desirable
• PM Certification (PMP) desirable

Additional Requirements

• Work Location: Hybrid