Global Regulatory Strategy Lead — Remote

Regulatory Jobs; United States; À distance; USD 120 000 - 170 000; Plein temps

Résumé du poste

Parexel is seeking a seasoned Regulatory Project Manager to translate strategy into action and drive globally aligned regulatory plans from development through post‑marketing. This remote, high‑impact role partners with Global Regulatory Leads to manage complex programs and ensure timely regulatory decisions.

You will lead cross‑functional teams, anticipate risks, and deliver proactive global regulatory plans, contributing to the delivery of transformative vaccines to patients worldwide.

Qualifications

• BA/BS degree in a scientific, engineering, or healthcare discipline required.
• Advanced degree (MS, PharmD, PhD) and/or PMP certification strongly preferred.

Responsabilités

• 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, risks, and opportunities.
• Lead execution of regulatory plans, ensuring alignment between daily operations and strategic objectives.
• Identify innovative regulatory pathways and planning scenarios.
• Collaborate with cross‑functional teams and senior leadership to drive clarity, alignment, and accountability for regulatory deliverables.

Connaissances

Regulatory strategy

Cross-functional collaboration

IND/BLA/MAA submissions

eCTD knowledge

Stakeholder communication

Formation

BA/BS in science, engineering, or healthcare

Advanced degree (MS/PhD) or PMP preferred

Outils

Smartsheet

PPT visuals (timeline/one-pager)

Veeva RIM

Description du poste

Parexel is seeking a seasoned Regulatory Project Manager to translate strategy into action and drive globally aligned regulatory plans from development through post‑marketing. This remote, high‑impact role partners with Global Regulatory Leads to manage complex programs and ensure timely regulatory decisions.

You will lead cross‑functional teams, anticipate risks, and deliver proactive global regulatory plans, contributing to the delivery of transformative vaccines to patients worldwide.