Hybrid Senior Manager, Regulatory Program Management – Submission Strategy, Oncology

at Pfizer

• Job title: Senior Manager, Regulatory Program Management – Submission Strategy, Oncology
• Job type: Full Time
• Experience level: Senior
• Salary: $124,400 - $201,400 per year
• Degree requirement: Bachelor's Degree
• Tech skills: PMP
• Location requirements: Hybrid, Collegeville, United States

About the role

• Senior Manager driving regulatory program management and submission strategies for Pfizer Oncology. Ensuring timely and quality regulatory deliverables across cross-functional teams.

Responsibilities

• Provides comprehensive program management, ensuring alignment and execution of Pfizer Oncology’s regulatory strategic and operational deliverables
• Responsible for ensuring all cross-functional regulatory deliverables are achieved on or ahead of schedule and with quality that meets or exceeds business needs
• Working with Global Regulatory Lead, responsible for the development of integrated regulatory plan and ensures alignment with the overall strategic and operational plan for the asset
• Offers 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
• Develop regulatory goals in partnership with the Global Regulatory Lead and closely monitors progress against these goals for operational efficiency ensuring the program delivers on time and within scope
• Ensures effective, accurate, and timely communication of regulatory information to meet the needs of the product team and stakeholders
• Provides comprehensive project management for regulatory submission activities for initial and supplemental market authorizations

Requirements

• Bachelor’s Degree with 6+ years of experience or Master’s Degree with 5+ years of experience
• Command of program management skills and considerable expertise in drug development (Oncology preferred)
• Professional PM Certification (Project Management Professional [PMP] or equivalent) desirable
• Experience with the 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 team environment
• Proven ability to drive results
• Knowledge and experience in drug development, medical, and/or commercial disciplines
• 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

• 401(k) plan with Pfizer Matching Contributions
• Additional Pfizer Retirement Savings Contribution
• Paid vacation
• Paid holiday
• Paid personal days
• Paid caregiver/parental leave
• Paid medical leave
• Health benefits including medical, prescription drug, dental, and vision coverage