Job Description

Overview

The Project Manager, Regulatory Affairs works as an integral part of the global Regulatory Affairs team to support the planning and execution of assigned Regulatory projects, guiding cross functional teams to ensure delivery of high-quality deliverables within agreed timelines. The role works closely with assigned Regulatory Project leads across the full range of Regulatory projects, from small consulting projects to large strategic programs, as necessary with guidance from a Senior PM or line Manager.

The role collaborates internally with colleagues in Medical Writing, CMC and publishing teams, Medical, Quality and PV, business development, finance, other consulting functions, and regulatory leadership, and externally with sponsors, clients, vendors, and contractors.

To fulfil this role, the candidate should have a regulatory background, combined with experience in project management and project governance.

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