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 pharmaceutical, biotechnology, or related life sciences industry, with at least 5 years in regulatory or regulatory program management.
• •Proven ability to partner on regulatory strategy and lead execution across all stages of product development, including IND/BLA/MAA submissions, global registration, and post-marketing activities.
• •Deep understanding of U.S. regulatory requirements with working knowledge of international (ex-U.S.) regulations and agency expectations.
• •Demonstrated success managing complex regulatory deliverables across cross-functional teams within a matrixed organization, while maintaining alignment to strategic priorities.
• •Hands-on experience with eCTD and a strong command of regulatory documentation, formatting, and submission strategy.
• •Experience supporting global development programs across multiple modalities or therapeutic areas is highly desirable.
• •Exceptional communication and influencing skills, with the ability to synthesize complex regulatory information and translate it into clear recommendations for senior leadership and global stakeholders.
• •Strong judgment and agility in managing competing priorities, resource constraints, and evolving program needs with flexibility and strategic foresight.
• •Demonstrated ability to leverage project management tools and best practices to enhance visibility, efficiency, cross-functional alignment, and meeting effectiveness across GRSTs and project teams.
• •Demonstrated experience facilitating cross-functional team meetings, driving structured agendas, documenting decisions and actions, and maintaining strong meeting hygiene and team accountability in a matrixed environment.
• •Committed to continuous learning and improvement, bringing an innovation mindset to regulatory execution and cross-functional collaboration.

Technical Skill Requirements

• •Expert skills required for Smartsheet and Microsoft Office Suite
• •Expert in creating visuals using PPT generated from timeline integration tools (ie, One Pager, Office Timeline Pro, etc.)
• •Proficient user of Veeva Regulatory Information Management (RIM)