Manager, Regulatory Program Management & Submission Strategy (Oncology)

Role Summary

The Manager, Regulatory Program Management & Submission Strategy (RPMSS) provides comprehensive regulatory program management support to align with Pfizer Oncology regulatory strategies and submission deliverables. This role coordinates regulatory activities, facilitates decision-making, and oversees information flow to ensure adherence to regulatory timelines and commitments. It 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 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

• Experience: 2-4+ years in the biopharmaceutical industry; oncology experience 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 demonstrated attention to detail.
• Excellent communication skills with the ability to respond with professionalism in verbal and written communications at all levels of the organization.
• Proficiency in MS Word, Excel, PowerPoint, and Outlook; understanding of MS Project is preferred.
• Ability to navigate a fast-paced, highly matrixed environment and collaborate across diverse teams.
• Resourceful, proactive, solution-oriented, and able to manage multiple priorities with tight timelines; sound judgment handling confidential information.
• Self-starter who works independently with limited supervision.

Education

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

Additional Requirements

• Work Location: Hybrid – onsite an average of 2.5 days per week