AD, Regulatory Project Manager

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a AD, Regulatory Project Manager based in the United States.

The Associate Director, Regulatory Project Manager will lead the coordination and execution of complex regulatory projects across global regulatory affairs and cross-functional teams.
This role translates regulatory strategy into actionable plans, critical paths, timelines, and measurable deliverables.
You will orchestrate regulatory submission activities from early development through marketing authorization, ensuring teams remain aligned and accountable.
The position combines project leadership, regulatory knowledge, stakeholder management, and agile ways of working in a highly collaborative environment.
You will facilitate decision-making, proactively identify risks and dependencies, and drive mitigation plans to protect critical milestones.
Working closely with regulatory leaders, asset teams, evidence teams, and other stakeholders, you will help ensure timely, accurate, and compliant submissions.
This is an opportunity for an experienced project leader to influence high-impact pharmaceutical programs while advancing operational excellence and continuous improvement.