Regulatory Manager, Clinical Trials Regulatory Management- Home-Based, Emea

.Prepares and / or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programsRESPONSIBILITIESActs as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customerAbility to administratively and technically / scientifically review core scientific documentation and feedback gap analysis to customers.Ability to write scientific documents e.G. Investigational Medicinal Product Dossier, clinical trial justificationsMay strategically plan and perform European centralized submissions and facilitate global country submissions on complex studies or programsMay provide support on key regulatory business development opportunities and complete Data Informed Protocol Assessments (DIPAs)Understands the Scope of Work, deliverables and budget for any given project and ensure timelines are met.Ensures accurate completion, maintenance and adherence to internal systems, databases, tracking tools and project plans in line with agreed SOPs (customer and / or IQVIA)