Director, Regulatory Program Management & Submission Strategy (Oncology)

Role Summary

Director, Regulatory Program Management & Submission Strategy (Oncology) responsible for comprehensive program management to align and execute regulatory strategic and operational deliverables for Pfizer Oncology. Acts as regulatory program operational leader to ensure cross-functional deliverables are achieved on or ahead of schedule with quality meeting business needs. Key leader on the Global Regulatory Strategy Team (GRST) with responsibilities spanning regulatory strategy, submission execution, team effectiveness, resource and risk management, and information/communication management.

Responsibilities

• Strategy and Planning: Develop integrated regulatory plans with Global Regulatory Lead; align with asset strategy and Partner Lines; manage from Pre-Clinical to Loss of Exclusivity; lead strategy development, scenarios, risk management, and stakeholder communications; design new processes or tools; define regulatory/submission critical path and milestones.
• Project Execution and Delivery: Provide cross-functional operational leadership to the Global Regulatory Strategy Team; monitor progress against goals; ensure on-time, in-scope delivery; manage resource allocation.
• Risk Analysis and Management: Lead integrated risk management plans; identify issues; escalate to senior leadership; develop de-risking options.
• Information and Communication Management: Ensure timely, accurate regulatory information to product teams and stakeholders; maintain timeline and resource data in systems for portfolio decisions.
• Team Effectiveness: Enhance cross-functional performance; ensure all views are considered; address performance issues; lead team chartering; manage deliverables and resources; influence GRST.
• Submissions: Manage regulatory submission activities for initial and supplemental market authorizations; map out submission contents 18 months in advance; optimize submission plans; develop endgame plans with project planner collaboration.

Qualifications

• Education: Bachelor's in drug development or business required; advanced degree (PhD, PharmD, MBA) desirable.
• Experience: 10+ years relevant experience; strong program management mastery in drug development (Oncology preferred); experienced with major regulatory submissions (NDA/BLA/MAA).
• Certifications: Professional PM Certification (PMP or equivalent) desirable.
• Skills: Proven leadership in complex matrix environments; strategic and operational thinking; strong negotiation, interpersonal, and facilitation skills; knowledge of clinical operations and end-to-end drug development; proficiency with Microsoft Project/Planisware/OnePager preferred.

Education

• Bachelor's degree in a relevant discipline; advanced degree desirable.

Additional Requirements

• Work Location: Hybrid