Electronic Warfare Program Manager overseeing critical EW contracts at a government facility. Leading program execution and maintaining strong customer relationships with strategic growth initiatives.
PF
Hybrid Senior Manager, Regulatory Program Management – Submission Strategy, Oncology
Posted 2 weeks ago
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
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