Pfizer · 9 hours ago
Senior Manager, Regulatory Program Management & Submission Strategy (Oncology)
Bothell, WA
Full-time
Hybrid
Mid, Senior Level
$124K/yr - $201K/yr
5+ years expPfizer is a leading pharmaceutical company seeking a Senior Manager for Regulatory Program Management & Submission Strategy in Oncology. This role involves comprehensive program management to ensure alignment and execution of regulatory deliverables, as well as leadership in regulatory strategy, project execution, risk management, and effective communication within cross-functional teams.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
No H1B
Responsibilities
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, as well as Partner Line plans for the program
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
Designs, recommends, and implements new processes, approaches, or tools to manage the program/team
Responsible for the development of the regulatory/submission critical path, decision criteria, and milestones/stage gates
Ensures alignment of regulatory/submission strategy with overarching asset strategy
Ensures all lines understand regulatory/submission strategy, key milestones, and interdependencies
Provides cross-functional operational expertise to the Global Regulatory Strategy Team
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
Monitors activities across all regulatory team members and associated lines to ensure achievement of key decision points and milestones according to time, cost, and quality parameters of the endorsed plan
Negotiates the allocation of Partner Line resources to support the endorsed regulatory/submission strategy
Directs the regulatory team in the preparation, implementation, maintenance, communication, and management of integrated risk management plans, including risk assessment and risk mitigation strategies
Proactively identifies operational issues, facilitates development of team recommendations and action options, and ensures appropriate escalation to senior leadership and Partner Lines
Partners with team and department leadership to identify options to de-risk project plans and capitalize on opportunities
Ensures effective, accurate, and timely communication of regulatory information to meet the needs of the product team and stakeholders
Provides complete, accurate, and timely timeline and resource information in appropriate Pfizer systems to enable effective portfolio management and decision making
Utilizes negotiation, facilitation, meeting management, and conflict resolution skills to enhance cross-functional team performance
Ensures all appropriate team member views have been raised and incorporated into team decisions as appropriate
Identifies team performance issues and partners with team leadership to recommend and develop appropriate actions
Leads team chartering process
Clarifies project deliverables/workload to enable Partner Lines to assess resource needs, raise gaps, and partner with team leadership to resolve
Seen as key member of the GRST with ability to influence
Provides comprehensive project management for regulatory submission activities for initial and supplemental market authorizations
Provides operational excellence, planning, and execution leading to successful regulatory submissions and approvals
Works with the team to map out submission contents and conduct scenario analyses of cost, schedule, and resource demands to identify the most efficient plan
Applies specialized knowledge of and expertise around endgame to contribute to the identification, evaluation, and optimization alternatives for the submission plan. May be responsible for the development of the submission integrated MS project plans and resourcing plans for endgame activities (partnership with Project Planner)
Qualification
Required
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)
Senior Managers are strongly preferred to have 6 or more years of relevant experience
Strong leadership, negotiation, interpersonal, communication, and meeting facilitation skills
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 with proven ability to think strategically and operationally
Demonstrated ability to translate strategy into effective operational goals and tactical plans
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
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact
Benefits
Participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% of the base salary
Eligibility to participate in our share based long term incentive program
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
Company
Pfizer
Pfizer is a biopharmaceutical company that discovers, develops, and delivers medicines and vaccines.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$38BKey Investors
Starboard Value
2025-11-21Post Ipo Debt· $6B
2024-10-07Post Ipo Equity· $1B
2023-05-16Post Ipo Debt· $31B
Leadership Team
Albert Bourla
Chief Executive Officer
Ian Read
Chief Executive Officer
Recent News
2026-02-09
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