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.
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.
Please apply here and RBW Consulting will be in touch on the next steps.
Regulatory CMC Project Manager in Portsmouth employer: RBW Consulting
Join a dynamic healthcare manufacturing site in Trefriw, North Wales, where you can make a significant impact as a Laboratory Supervisor. We offer a supportive and collaborative work culture that prioritises professional growth, with opportunities to lead a dedicated team and influence quality standards. Enjoy a competitive salary, career development prospects, and the chance to work in a beautiful location while contributing to meaningful advancements in laboratory science and compliance.
