FSP - Sr Regulatory Program Manager - client dedicated

Thermo Fisher Scientific•Morrisville, NC

4d•Onsite

About The Position

This experienced regulatory project manager partners with Global Regulatory Leads to shape and execute comprehensive regulatory strategies and plans for U.S. and ex-U.S. markets across product development, registration, and post-marketing. The role translates strategy into actionable plans with milestones, critical paths, risks, and opportunities, and leads execution in alignment with broader program objectives. As a visible, cross-functional member of the Global Regulatory Science team, the position aligns stakeholders, manages complex timelines and interdependencies, anticipates challenges, and supports timely regulatory decision-making and delivery of program milestones. The role also facilitates Global Regulatory Subteam (GRST) meetings and other project forums, maintaining effective governance, agendas, decision and action records, follow-up, communication, and meeting practices. The position prepares strategic dashboards, reports, and scenario plans for senior stakeholders, and identifies solutions to regulatory project and operational challenges. It supports regulatory execution for global programs and submission readiness, including IND, BLA, and MAA submissions, global registration, and post-marketing activities.

Requirements

BA/BS degree in a scientific, engineering, or healthcare discipline.
At least 7 years of progressive experience in the pharmaceutical, biotechnology, or related life sciences industry, including at least 5 years in regulatory or regulatory program management.
Experience partnering on regulatory strategy and leading execution across product development, including IND/BLA/MAA submissions, global registration, and post-marketing activities.
Deep understanding of U.S. regulatory requirements and working knowledge of international (ex-U.S.) regulations and agency expectations.
Demonstrated success managing complex regulatory deliverables across cross-functional teams in a matrixed organization while maintaining strategic alignment.
Hands-on experience with eCTD and strong knowledge of regulatory documentation, formatting, and submission strategy.
Exceptional communication and influencing skills, including the ability to synthesize complex regulatory information into clear recommendations for senior leadership and global stakeholders.
Strong judgment and agility managing competing priorities, resource constraints, and evolving program needs.
Ability to use project management tools and practices to improve visibility, efficiency, cross-functional alignment, and meeting effectiveness.
Experience facilitating cross-functional meetings, structuring agendas, documenting decisions and actions, and maintaining meeting hygiene and team accountability in a matrixed environment.
Commitment to continuous learning and improvement and an innovation mindset in regulatory execution and cross-functional collaboration.
Expert skills in Smartsheet and Microsoft Office Suite.
Expertise creating PowerPoint visuals using timeline integration tools such as One Pager or Office Timeline Pro.
Proficient user of Veeva Regulatory Information Management (RIM).

Nice To Haves

Advanced degree (MS, PharmD, or PhD).
PMP certification.
Experience supporting global development programs across multiple modalities or therapeutic areas.

Responsibilities

Partner with Global Regulatory Leads to shape and execute forward-looking, globally aligned regulatory plans across development and post-marketing.
Translate regulatory strategy into actionable plans with milestones, critical paths, risks, and opportunities.
Lead execution of regulatory plans, aligning operational activities with strategic objectives across global programs.
Identify and propose regulatory pathways and planning scenarios aligned with regulatory expectations and business objectives.
Collaborate with cross-functional teams and senior leadership to align regulatory deliverables, timelines, and interdependencies.
Facilitate GRST meetings and other project review forums, supporting decision-making, risk mitigation, and regulatory execution.
Develop and distribute meeting agendas, define objectives and discussion topics, maintain action logs, document decisions and next steps, track follow-up to closure, and communicate and store materials appropriately.
Maintain GRST governance, meeting cadence, stakeholder alignment, and communication flow across global and regional teams.
Anticipate and resolve regulatory project and operational challenges, implementing solutions that improve team effectiveness, process efficiency, and submission readiness.
Prepare and deliver strategic dashboards, reports, and scenario plans that translate regulatory progress and risks into actionable business insights.