RD Project Manager
LMW, Greece

lmw is seeking an Ramp;D Project Manager on behalf of a generic manufacturing company based in Athens.

Responsibilities

• Manage CMC activities for assigned projects at all stages of Ramp;D.
• Establish strategies that meet project and regulatory requirements.
• Develop and maintain suitable project schedules, budgets and risk mitigation plans with project teams and external service providers.
• Liaise with service providers to monitor progress against milestones, as well as resolve technical, quality or resource issues smoothly.
• Review and manage technical data and documentation to ensure timely action, compliant storage and efficient retrieval.
• Prepare project updates, presentations and reports for both internal and external stakeholders.
• Prepare regulatory documentation (non-clinical and quality modules) and support regulatory submissions.

• In collaboration with Procurement, identify and evaluate potential external service providers, taking into account technical capabilities, quality requirements and cost-effectiveness.
• Organize quality agreements and audit schedules for service providers, monitor and improve their performance, and maintain a qualified service providers list.
• Support the development, implementation, maintenance and monitoring of quality systems to ensure compliance with GLP, GMP and GDP requirements.
• Manage standard operating procedures relating to pharmaceutical quality.

Requirements

• 3+ years of experience in an Ramp;D department
• Bachelor's Degree in Chemistry, Pharmacy or relevant, a post graduate degree will be highly valued
• Robust knowledge of non-clinical safety studies, CMC activities, and regulatory requirements
• Expertise in project management within a multidisciplinary Ramp;D environment
• Experience in managing international relationships with external project partners and service providers
• Fluency in English
• Expert use of MS Suite, as well as a planning software
• Availability to travel abroad when required

Benefits

The company offers an international standards work environment with real opportunities for career development.

Job Rewards and Benefits