Manager, Regulatory Program Management & Submission Strategy (Oncology)

Job description

JOB SUMMARY: The Manager, Regulatory Program Management & Submission Strategy (RPMSS) provides comprehensive regulatory program management support that ensures alignment with and execution of Pfizer Oncology’s regulatory strategies and submission deliverables. This position is accountable for coordination and prioritization of regulatory activities, facilitation of decision-making processes, and oversight of information flow to ensure adherence to regulatory timelines and commitments. The Manager, RPMSS plays a critical role in partnering with regulatory strategists to advance regulatory and submission activities for assigned programs within the oncology portfolio. JOB RESPONSIBILITIES: The Manager, RPMSS will provide comprehensive support to Pfizer Oncology’s Global Regulatory Strategy Teams (GRST) and Submission Teams, ensuring efficient execution in accordance with program strategy. Responsibilities include, but are not limited to: 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...