Manager, Regulatory Program Management & Submission Strategy (Oncology)

Role Summary

The Manager, Regulatory Program Management & Submission Strategy (RPMSS) provides regulatory program management support to ensure alignment with Pfizer Oncology regulatory strategies and submission deliverables. This position coordinates regulatory activities, prioritizes tasks, facilitates decision-making, and oversees information flow to meet regulatory timelines. The role 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

• Required: Bachelor’s Degree with 4+ years of experience or Master’s Degree with 2+ years of experience.
• Required: 2-4+ years of experience in the biopharmaceutical industry.
• Preferred: Oncology experience.
• Preferred: Experienced in managing day-to-day planning and project management to enable execution of complex strategies.
• Preferred: Experienced in communicating and interacting with senior executive stakeholders.
• Preferred: Experienced in managing multiple, competing tasks simultaneously.
• Preferred: Demonstrated ability to work collaboratively with diverse teams and manage a team of cross-functional colleagues.
• Preferred: Demonstrated understanding of systems and structures, and ability to implement efficient processes.
• Preferred: Demonstrated resourcefulness with proven ability to anticipate needs, prioritize responsibilities, and manage multiple priorities with tight timelines.
• Preferred: Strong project management skills with demonstrated attention to detail.
• Preferred: High energy level, sense of urgency, creativity, decisiveness, and ability to work under pressure.
• Preferred: Demonstrated strong self-starter, independent, proactive, solutions oriented, and self-motivated.
• Preferred: Ability to exhibit sound judgment in handling confidential information.
• Preferred: Ability to work well both in a team environment as well as independently with limited direct supervision.
• Preferred: Excellent communication skills with professionalism in verbal and written communications at all levels of the organization.
• Preferred: Proficiency in MS Word, Excel, PowerPoint, and Outlook; understanding of MS Project is preferred.
• Preferred: Know and model Pfizer Values and Pfizer Core Competencies.
• Preferred: 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

Skills

• Demonstrated resourcefulness with the ability to anticipate needs, prioritize responsibilities, and manage multiple priorities with tight timelines.
• Strong project management and attention to detail.
• High energy, sense of urgency, creativity, decisiveness; ability to work under pressure.
• Self-starter, independent, proactive, solutions-oriented, and self-motivated.
• Ability to handle confidential information with sound judgment.
• Ability to work well in a team and independently with limited supervision.
• Excellent communication skills and professionalism in verbal and written communications across all levels.
• Proficiency in MS Word, Excel, PowerPoint, and Outlook; familiarity with MS Project is preferred.
• Collaborative mindset and ability to navigate a fast-paced, highly matrixed environment.

Additional Requirements

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