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
• Tech skills: PMP
• Location requirements: Hybrid, Collegeville, United States

About the role

• Director of Regulatory Program Management at Pfizer leading oncology drug development compliance. Overseeing program deliverables and cross-functional regulatory submissions in the oncology sector.

Responsibilities

• Provides comprehensive program management
• Ensures alignment and execution of Pfizer Oncology’s regulatory strategic and operational deliverables
• Serves as the regulatory program operational leader
• Ensures all cross-functional regulatory deliverables are achieved on or ahead of schedule
• Works with Global Regulatory Lead to develop integrated regulatory plan
• Provides cross-functional operational leadership
• Monitors activities across all regulatory team members
• Leads the regulatory team in the preparation 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

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)
• 10 or more years of relevant experience preferred
• Professional PM Certification (Project Management Professional [PMP] or equivalent) desirable
• Experience leading the planning and execution of major regulatory submissions (e.g. NDA/BLA/MAA) is required
• Extensive knowledge and experience in drug development, medical, and/or commercial disciplines
• Demonstrated ability to translate strategy into effective operational goals and tactical plans
• Knowledge of and experience with clinical operations/clinical trial execution is desirable
• Experience with Microsoft Project, Planisware, and/or OnePager is preferred

Benefits

• 401(k) plan with Pfizer Matching Contributions and an 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