Senior Regulatory Project Leader – Global Vaccine Programs

Parexel; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Parexel is seeking an experienced Regulatory Project Manager in the United States to lead globally aligned regulatory plans across development and post‑marketing. You will partner with Global Regulatory Leads to drive strategies, manage complex timelines, and deliver submission readiness with cross‑functional teams.

You will facilitate GRST governance, develop strategic dashboards, and translate regulatory progress into actionable insights for senior leadership.

Qualifications

• BA/BS in scientific, engineering, or healthcare discipline required; advanced degree strongly preferred.
• Minimum 7 years of progressive experience in pharma/biotech, with at least 5 years in regulatory or regulatory program management.
• Experience supporting IND/BLA/MAA submissions, global registration, and post‑marketing activities.

Responsibilities

• 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 milestones, critical paths, risks, and opportunities.
• 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 with cross‑functional teams and senior leadership to drive clarity, alignment, and accountability for regulatory deliverables, timelines, and interdependencies.
• Facilitate GRST meetings and other review forums with purposeful structures and outcomes, documenting decisions and actions.
• Apply PM best practices for meeting management, agendas, action logs, and follow‑ups.

Skills

Regulatory project management

Strategic planning

Cross-functional leadership

Regulatory submissions

Communication

Education

BA/BS in scientific/engineering/healthcare

MS/PhD/PharmD (advanced degree)

PMP certification

Tools

Smartsheet

Microsoft Office

PowerPoint

Veeva RIM

Job description

Parexel is seeking an experienced Regulatory Project Manager in the United States to lead globally aligned regulatory plans across development and post‑marketing. You will partner with Global Regulatory Leads to drive strategies, manage complex timelines, and deliver submission readiness with cross‑functional teams.

You will facilitate GRST governance, develop strategic dashboards, and translate regulatory progress into actionable insights for senior leadership.