Project Manager - Rare & Breakthrough Drug Submissions

Job Title: Project Manager - Rare & Breakthrough Drug Submissions

Location: European Union (Remote)
Duration: 6 months (with potential extension)
Workload: To be defined

About the Role:
We are seeking an experienced Project Manager to support a cross-functional team in preparing a comprehensive data package for breakthrough and orphan drug designation, with the ultimate goal of rare disease registration. The role involves coordinating multiple departments, managing timelines, and ensuring successful delivery of regulatory submissions.

Key Responsibilities:

• Coordinate and schedule cross-functional meetings; manage agendas and minutes using Copilot transcript tools.
• Track project risks, challenges, and roadblocks; develop and implement mitigation plans.
• Identify, monitor, and optimize required resources (FTE and OPEX) to meet project timelines.
• Support communication with senior leadership, ensuring transparent and timely updates.
• Manage project deliverables, timelines, and dependencies across teams.

Required Skills and Experience:

• Proven experience in project management within the pharmaceutical or biotech industry.
• Strong understanding of FDA submission processes and requirements.
• Experience managing senior subject matter experts indirectly.
• Excellent planning, organizational, and communication skills.

Preferred Skills:

• Knowledge of rare disease regulatory pathways and orphan drug approval processes.
• Familiarity with project management tools and digital collaboration platforms.

What We Offer:

• Opportunity to contribute to breakthrough and rare disease therapies.
• Remote work across the European Union.
• Collaboration with a high-performing, cross-functional team.