Senior Manager, Regulatory Program Management & Submission Strategy (Oncology)

Role Summary

The Senior Manager, Regulatory Program Management & Submission Strategy (RPMSS) provides comprehensive program management, ensuring alignment and execution of Pfizer Oncology’s regulatory strategic and operational deliverables. The Senior Manager, RPMSS is responsible for ensuring all cross-functional regulatory deliverables are achieved on or ahead of schedule and with quality that meets or exceeds business needs. The Senior Manager, RPMSS is viewed as a key member of the GRST (Global Regulatory Strategy Team). The Senior Manager, RPMSS’ responsibilities encompass regulatory strategic and scenario planning, execution of regulatory and submission deliverables, team effectiveness, resource management, risk management, and information and communication management. The Senior Manager, RPMSS needs to have a comprehensive understanding of strategic and tactical planning and the foundational tools that support planning, communication, and continuous improvements in operational delivery.

Responsibilities

• Strategy and Planning
  • 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.
• Project Execution and Delivery
  • 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.
• Risk Analysis and Management
  • 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.
• Information and Communication Management
  • 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.
• Team Effectiveness
  • 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.
• Submissions
  • 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).

Qualifications

• 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.
• 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.
• 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.
• 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.

Education

• Bachelor’s Degree with 6+ years of experience or Master’s Degree with 5+ years of experience
• Professional PM Certification (PMP or equivalent) desirable

Additional Requirements

• Work Location: Hybrid — onsite on average 2.5 days per week.