FSP - Sr Regulatory Program Manager

Thermo Fisher Scientific seeks a senior regulatory program manager to lead global regulatory strategy execution across development, registration, and post-marketing stages for mRNA medicines. This remote role in North Carolina requires partnering with regulatory leads, managing complex timelines, facilitating cross-functional meetings, and delivering strategic insights to senior stakeholders.

Responsibilities

• Partner with Global Regulatory Leads to develop and execute comprehensive, globally aligned regulatory plans
• Translate regulatory strategy into actionable plans with clear milestones, critical paths, risks, and opportunities
• Lead Global Regulatory Subteam meetings with structured agendas, decision documentation, and action tracking
• Identify innovative regulatory pathways and planning scenarios aligned with global expectations and business objectives
• Prepare strategic dashboards and reports translating regulatory progress into business insights for senior stakeholders

Requirements

• BA/BS in scientific, engineering, or healthcare discipline; MS, PharmD, PhD, or PMP certification preferred
• Minimum 7 years pharmaceutical/biotech industry experience; at least 5 years in regulatory or regulatory program management
• Expertise in IND/BLA/MAA submissions, global registration, and post-marketing regulatory activities
• Deep knowledge of U.S. regulations with working familiarity of international regulatory requirements
• Hands-on experience with eCTD and regulatory documentation formatting for submissions
• Strong project management and cross-functional leadership in matrixed organizations
• Excellent communication skills translating complex regulatory information for senior leadership