Consultant – Regulatory Affairs Project Manager

• Lead the execution of the global submission plan across the entire product lifecycle
• Anticipate operational risks and manage planning and timelines
• Structure the dossier hierarchy and coordinate the collection of documents
• Oversee publishing vendors and coordinate the preparation of responses to health authority queries

Requirements

• Minimum 10 years' experience in project management within a demanding Regulatory Affairs environment
• Strong knowledge of eCTD dossiers and international submission processes
• Fluent English