Project Manager

The organisation

Your new company is based in the Amsterdam area and is focused on developing innovative gene therapy treatments for patients with serious unmet medical needs. As the company moves through regulatory review and prepares for commercial launch, they are seeking an experienced Project Manager to drive cross-functional execution across Regulatory, Quality, CMC, and Supply Chain teams.

The position

The Project Manager is responsible for coordinating and driving project execution during regulatory review and launch readiness activities. The role focuses on ensuring accountability, tracking deliverables, managing risks and dependencies, and maintaining alignment across multiple stakeholders without direct line management authority. The successful candidate will support activities spanning CMC regulatory review, Global Quality launch readiness, and Commercial Supply Chain readiness.

Tasks & responsibilities

• Track and coordinate CMC activities supporting BLA and MAA regulatory review processes.
• Monitor progress of regulatory Q&A responses and escalate potential delays.
• Organize meetings, track actions, and ensure closure of regulatory review activities.
• Maintain and manage quality launch readiness trackers, including change controls, deviations, CAPAs, and inspection readiness activities.
• Track commercial launch lots, specification updates, labeling changes, batch record updates, and related documentation.
• Build and maintain an integrated global launch plan covering Regulatory, Quality, CMC, and Supply Chain workstreams.
• Manage project risks, actions, issues, and decisions through RAID logs and contingency planning.
• Track critical path activities, dependencies, and vendor deliverables to ensure launch timelines are achieved.
• Support go/no-go launch readiness reviews through accurate status reporting and dashboard management.
• Coordinate activities across internal teams, CDMOs, CMOs, and external vendors.
• Standardize project reporting, documentation, meeting minutes, and governance processes.

Candidate profile

What you'll need to succeed

• Minimum of 8 years of project management experience within pharmaceutical, biotechnology, CMC, Quality, or Supply Chain environments.
• Experience supporting BLA and/or MAA regulatory review activities.
• Strong understanding of regulatory submission processes, agency timelines, and Q&A management.
• Proven experience managing complex cross-functional projects involving external vendors and manufacturing partners.
• Knowledge of GMP change controls, QMS processes, and launch readiness activities.
• Experience with integrated project planning, critical path management, dependency mapping, and RAID management.
• Excellent communication and stakeholder management skills.
• Experience with project management tools such as MS Project, Smartsheet, or equivalent.
• Fluency in English.

The offer

This is an opportunity to contribute to the regulatory approval and commercial launch of an innovative gene therapy product while working with international teams across Quality, Regulatory Affairs, Manufacturing, and Supply Chain functions.

Interested?

You are invited to apply for this position by following the link below.