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.

Apply now, read the job details by scrolling down Double check you have the necessary skills before sending an application.

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

Key Responsibilities:

• 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.

Requirements:

• 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).
• Fluent English
• Able to work within EU/UK or US East Coast time zones.

Key Skills:

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

Please apply here and RBW Consulting will be in touch on the next steps.