Global Launch Project Manager (Pharma/Biotech)

Vacatures Zaandam; Zaandam; On-site; EUR 90,000 - 120,000; Full time

Job summary

Your new company in the Amsterdam area is seeking an experienced Project Manager to drive cross-functional execution across Regulatory, Quality, CMC, and Supply Chain teams during regulatory review and launch readiness.

You will coordinate and manage complex programs, track deliverables, mitigate risks, and maintain alignment with external vendors and CMOs while ensuring on-time product launches.

Qualifications

• Minimum of 8 years of project management experience in 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.

Responsibilities

• Track and coordinate CMC activities supporting BLA and MAA regulatory review processes.
• Monitor progress of regulatory Q&A responses and escalation 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.

Skills

Project management

Regulatory submissions

Cross-functional leadership

Stakeholder management

Communication

Project planning

Risk management

MS Project/Smartsheet

Tools

MS Project

Smartsheet

Job description

Your new company in the Amsterdam area is seeking an experienced Project Manager to drive cross-functional execution across Regulatory, Quality, CMC, and Supply Chain teams during regulatory review and launch readiness.

You will coordinate and manage complex programs, track deliverables, mitigate risks, and maintain alignment with external vendors and CMOs while ensuring on-time product launches.