Hybrid Director, Regulatory Program Management – Submission Strategy, Oncology

at Pfizer

• Job title: Director, Regulatory Program Management – Submission Strategy, Oncology
• Job type: Full Time
• Experience level: Lead
• Salary: $169,700 - $282,900 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Collegeville, United States

About the role

• Director overseeing regulatory program management and submission strategy in Oncology. Leading execution and alignment of regulatory deliverables to meet business needs and timelines.

Responsibilities

• Provides comprehensive program management, ensuring alignment and execution of Pfizer Oncology’s regulatory strategic and operational deliverables
• Serves as the regulatory program operational leader, ensuring all cross-functional regulatory deliverables are achieved on or ahead of schedule
• Offers leadership in regulatory strategy and planning
• Ensures alignment of regulatory/submission strategy with overarching asset strategy
• Provides cross-functional operational leadership to the Global Regulatory Strategy Team
• Influences leadership across functional lines to ensure efficient delivery of regulatory projects
• Leads the regulatory team in the preparation, implementation, maintenance, communication, and management of integrated risk management plans
• Ensures effective, accurate, and timely communication of regulatory information
• Utilizes negotiation, facilitation, meeting management, and conflict resolution skills to enhance cross-functional team performance
• Provides comprehensive project management for regulatory submission activities for initial and supplemental market authorizations

Requirements

• Bachelor's degree in one of the disciplines related to drug development or business required
• Advanced degree (PhD, PharmD, MBA) desirable
• Mastery of program management skills and significant expertise in drug development (Oncology preferred)
• Directors are strongly preferred to have 10 or more years of relevant experience
• Experience leading the planning and execution of major regulatory submissions (e.g. NDA/BLA/MAA) is required
• Strong track record of performance, delivery and team effectiveness in a complex matrix team environment
• Proven ability to drive results
• Extensive knowledge and experience in drug development, medical, and/or commercial disciplines with proven ability to think strategically and operationally
• Demonstrated ability to translate strategy into effective operational goals and tactical plans
• Strong leadership, negotiation, interpersonal, communication, and meeting facilitation skills
• Knowledge of and experience with clinical operations/clinical trial execution is desirable
• Knowledge of end-to-end drug development (pre-clinical through LOE) is desirable
• Experience with Microsoft Project, Planisware, and/or OnePager is preferred.

Benefits

• comprehensive and generous benefits and programs to help our colleagues lead healthy lives
• 401(k) plan with Pfizer Matching Contributions
• additional Pfizer Retirement Savings Contribution
• paid vacation
• holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage