Manager, Regulatory Program Management & Submission Strategy (Oncology)

Role Summary

The Manager, Regulatory Program Management & Submission Strategy (RPMSS) provides regulatory program management support aligned with Pfizer Oncology’s regulatory strategies and submission deliverables. This role coordinates and prioritizes regulatory activities, facilitates decision-making processes, and oversees information flow to ensure adherence to regulatory timelines and commitments. The RPMSS partners with regulatory strategists to advance regulatory and submission activities for assigned oncology programs.

Responsibilities

• Develop and manage submission timelines and milestones using appropriate tools. Identify efficiencies to enable fast filings and convert submission timelines into clear, actionable tasks with proactive follow-up to ensure on-time delivery.
• Contribute to the design and implementation of processes that enhance workflow efficiency and provide guidance on best practices and procedures.
• Organize and manage GRST, Submission Team, MCI and other leadership pre-alignment meetings, including scheduling, agenda preparation, material distribution, minute-taking, action item follow-up, and appropriate storage of all documentation.
• Proactively identify and resolve project issues to meet productivity, quality, and organizational goals.
• Lead or co-lead projects, effectively managing time and resources for oneself, with consideration of impact on team members.
• Develop and maintain templates, dashboards, team rosters, document reviewer lists, SharePoint/Teams sites, and action trackers.
• Independently prepare comprehensive status reports, timelines, tables, graphs, correspondence, and presentations as needed for internal and external stakeholders.
• Track and analyze metrics to support business insights.
• Assist with onboarding of new team members and provide training and guidance for new project system users.

Qualifications

• 2-4+ years of experience in the biopharmaceutical industry – oncology preferred
• Experienced in managing day-to-day planning and project management to enable execution of complex strategies
• Experienced in communicating and interacting with senior executive stakeholders
• Experienced in managing multiple, competing tasks simultaneously
• Demonstrated ability to work collaboratively with diverse teams and manage a team of cross-functional colleagues
• Demonstrated understanding of systems and structures, and ability to implement efficient processes

Skills

• Strong project management skills with attention to detail
• High energy level, sense of urgency, creativity, decisiveness, and ability to work under pressure
• Demonstrated strong self-starter, independent, proactive, solutions-oriented, and self-motivated
• Ability to exhibit sound judgment in handling confidential information
• Ability to work well both in a team environment as well as operate independently with limited supervision
• Excellent communication skills with professionalism in verbal and written communications with all levels of the organization
• Proficiency in MS Word, Excel, PowerPoint, and Outlook; understanding of MS Project is preferred
• Know and model Pfizer Values and Pfizer Core Competencies
• Excellent collaborator and ability to navigate a fast-paced, highly matrixed environment

Education

• Bachelor’s Degree with 4+ years of experience or Master’s Degree with 2+ years of experience

Additional Requirements

• Work Location Assignment: Hybrid - must be onsite an average of 2.5 days per week.