Regulatory CMC Project Manager

RBW Consulting are partnered with a growing medium sized global Pharmaceutical organisation in their search for a Dossier Delivery Regulatory CMC Project Manager.

We are seeking an experienced CMC Regulatory Project Manager to support the tracking, review, and approval of CMC submission documents for global regulatory filings.

• Manage CMC dossier trackers, timelines, and document status updates.
• Coordinate review, approval, and comment resolution processes with technical and regulatory stakeholders.
• Lead tracking meetings and provide progress updates to project teams and submission managers.
• Oversee document management within Veeva Regulatory Vault.
• Ensure documentation is collected, reviewed, and delivered to agreed deadlines.
• Support the preparation and delivery of regulatory response dossiers.

• 3+ years' experience in a CMC, regulatory, or project coordination/management environment.
• Experience managing projects within a CMC setting.
• Understanding of NDA/MAA submissions and CTD structure.
• Knowledge of drug manufacturing and control processes.
• Degree in a scientific or technical discipline.
• Strong working knowledge of Excel, PowerPoint, SharePoint, databases, and document management systems (Veeva Vault preferred).
• Able to work within EU/UK or US East Coast time zones.

• Highly organised with strong attention to detail.
• Comfortable managing multiple priorities simultaneously.
• Excellent communication and stakeholder management skills.