FSP - Sr Regulatory Program Manager

Work Schedule Standard Office Hours (40/wk) Environmental Conditions Office Job Description Role Summary This role is designed for an experienced and forward-thinking regulatory project manager who thrives in a fast-paced, innovative environment and can seamlessly integrate strategic thinking with operational execution across all stages of product development, registration, and post-marketing. As a key member of the Global Regulatory Science team, you will partner strategically with Global Regulatory Leads to shape and execute comprehensive regulatory strategies for the U.S. and ex-U.S. markets. You will lead the development and execution of proactive global regulatory plans that articulate clear milestones, surface risks and opportunities, and support timely, informed regulatory decision-making. This is a highly visible, cross-functional role requiring strong leadership, agility, and strategic foresight. You will be accountable for driving regulatory excellence by aligning cross-functional stakeholders, managing complex timelines, and anticipating challenges to enable successful delivery of regulatory milestones that support the clients' mission to bring transformative mRNA medicines to patients worldwide. In close partnership with Global Regulatory Leads, you will also play a key role in facilitating Global Regulatory Subteam (GRST) meetings and subteam forums, ensuring effective meeting structure, clear agendas, documented decisions and actions, timely follow-up, and strong meeting hygiene consistent with project management best practices. This includes helping teams operate with clarity, accountability, and a high-performance mindset through disciplined planning, communication, and execution. Here’s What You’ll Do Partner strategically with Global Regulatory Leads to shape and execute forward-looking, globally aligned regulatory plans across all stages of development and post-marketing. Translate regulatory strategy into integrated, actionable plans with clear milestones, critical paths, risks, and opportunities to support effective planning and decision-making. Lead the execution of regulatory plans, ensuring alignment between day-to-day operations and broader strategic objectives across global programs. Identify and propose innovative regulatory pathways and planning scenarios that align with global regulatory expectations and business objectives. Collaborate closely with cross-functional teams and senior leadership to drive clarity, alignment, and accountability for regulatory deliverables, timelines, and interdependencies. Facilitate Global Regulatory Subteam (GRST) meetings and other routine and ad hoc project review forums, ensuring meetings are purpose-driven, well-structured, and focused on decision-making, risk mitigation, and regulatory execution. Apply project management best practices for meeting management and hygiene, including developing and distributing agendas in advance, defining objectives and discussion topics, maintaining action logs, documenting key decisions and next steps, tracking follow-up items to closure, and ensuring materials are stored and communicated appropriately. Partner with Global Regulatory Leads and cross-functional stakeholders to maintain effective GRST governance, meeting cadence, stakeholder alignment, and communication flow across global and regional teams. Anticipate and troubleshoot complex regulatory project and operational challenges, implementing scalable solutions that strengthen team effectiveness, process efficiency, and submission readiness. Prepare and deliver strategic dashboards, reports, and scenario plans to senior stakeholders, translating regulatory progress and risks into actionable business insights. Here’s What You’ll Bring to the Table BA/BS degree in a scientific, engineering, or healthcare discipline required; advanced degree (MS, PharmD, PhD) and/or PMP certification strongly preferred. Minimum of 7 years of progressive experience in the